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Ahsan Zamir Siddiqi, Director Quality Operations

Ahsan Zamir Siddiqi

Director Quality Operations·Highnoon Laboratories

Pakistan

Doctorate, Pharmaceutical Chemistry

Work experience

Total years of experience: 28 years, 3 months

Director Quality Operations

January 2019 - Present

Highnoon Laboratories

Lahore, Pakistan

January 2019 - Present

• Responsible for running of Quality Operations Division covering areas of quality control, quality assurance, quality support, quality systems policy development and implementation, GMP training and audit, validation, and stability studies.
• In coordination with management team, develop a strategy for global quality compliance, develop company quality plan and implement quality management system at the site.
• Ensure quality compliance in lines with DRAP, PIC/S, WHO GMP Guidelines & support RA in Regulatory Inspections and MOH matters related to Registrations.
• Work on QO Divisional budget and Capex for approval
• Prepare the QO division Objectives in line with Corporate objective and ensure its communication and follow up to the floor level.
• Ensure Manpower, departmental expenses, overtime and CAPEX are in lines with the set objectives.
• Support Regulatory Affair for new product dossier, dossiers on CTD format as per requirement of DRAP and different countries.
• Ensure that a robust process is in place for vendor qualification, internal and external audits, Change Control process, CAPA Management, Quality Risk Assessment.
• Ensure validations of facilities, processes, Analytical Methods and Cleaning Methods are complete and records are maintained.
• Approval of specification, test methods, SOPs and documents effecting product quality
• Supervise the product Recall investigations and completion of the CAPA plans
• Regularly review Quality Operations Division performance
• Work with procurement in their initiative for source change by evaluating and approving the new source based on scientific findings as per DRAP & PIC/S GMP guidelines.
• Develop a training process jointly with HR & ensure /conduct/support training of technical QMS at the company.
• Support in new Product Development by ensuring that testing of materials and new products for Quality and safety are completed timely.
• Ensure a robust Audit process is in place.
• Communication with toll partners including Abbott METAP region.
Company industry:
Pharmaceutical Manufacturing
Job role:
Quality Control

Head of Plant Operations

May 2016 - December 2018

Highnoon Laboratories

Lahore, Pakistan

May 2016 - December 2018

• Responsible to look after all plant related activities like Production, Quality Control, Quality Assurance, Validation & Compliance, and Engineering department.
• Led the commissioning and qualification of production machineries (machineries of dry powder for injectable and oral solid dosage forms), utility block (purified water treatment plant, water for injection plant, cleaned steam generator, oil free compressor) and Quality control equipment’s.
• Manage validation team to support the validation activities which includes process validation, cleaning validation
• Member of new products development committee to coordinate the development, manufacturing and launching of new products.
• Generated Validation Master plans for process, equipment’s and cleaning procedures.
• Coordinated with supply chain department to develop new vendors for APIs, excipients and packaging material.
• Lead audit with successful result by DRAP for Drug Manufacturing License
Company industry:
Pharmaceutical Manufacturing
Job role:
Manufacturing

Plant Manager

February 2013 - April 2016

Saffron Pharmaceutical (Pvt) Ltd.

Faisalabad, Pakistan

I found this job using Bayt.com

February 2013 - April 2016

•Responsible to look after all plant related activities like Production, Material Management, Engineering, Quality Control, Quality Assurance, Validation and Compliance.
•Responsible to manage technical operations in Plant according to the cGMP/WHO requirements.
•Responsible for the proper implementation of ISO 9001: 2008 Quality Management System, ISO 14001 Environmental Management System in Plant and ISO 17025 Laboratory accreditation in QC Lab.
Company industry:
Pharmaceutical Manufacturing
Job role:
Management

Clinical Pharmacist

March 2011 - February 2013

King Khalid University and Hospital, Riyadh, Saudi Arabia

Riyadh, Saudi Arabia

March 2011 - February 2013

Clinical Pharmacist
Company industry:
Medical Hospital
Job role:
Medical, Healthcare, and Nursing

Manager Quality Assurance and Regulatory Affairs/Quality Control

August 2008 - March 2011

CCL PHARMACEUTICALS, Lahore, Pakistan

Lahore, Pakistan

August 2008 - March 2011

• Responsible to look after the activities of Quality Assurance (Quality Control, Inprocess control, Product development, Validation and regulatory affairs).
• Responsible for making, implementing and documenting the policies, procedures, specifications and methods to assure the quality of products.
• Overall responsibility for compiling regulatory submissions for different countries (on CTD format/WHO guideline), drafting Product Information, literature searches to support submissions, and other regulatory activities.
• Conduction of audit from different regulatory authorities local and international (Kenya, Sudan).
• To manage the Quality Control Laboratory and make positive and energetic contribution in the improvement and consolidation of the total Quality Control system.
• To lead R&D for development of new testing methods.
• To have a final check of batch manufacturing record and signing on GMP compliance certificate for its release to be sale.
• To conduct GMP/GLP inspections according to schedule and ensure the compliance of procedures, SOPs in all technical departments.
• To monitor stability studies e.g. planning for taking stability samples, schedules of stability, review of stability results.
• Customer complaint handling, i.e. receiving, investigation, review of complaints and making comparative data of complaint.
• To monitor deviation in the batch / processes and its approval and recording.
• To coordinate with Procurement Department in conducting supplier audit / inspection and making its report.
• To look after the activities of validations.
• Planning and scheduling the product development work as new & old formulation with testing and manufacturing process.
Company industry:
Pharmaceutical Manufacturing
Job role:
Quality Control

Senior Manager Quality Control

November 2007 - August 2008

ASKARI PHARMACEUTICALS, Lahore

Lahore, Pakistan

November 2007 - August 2008

• Responsible to look after the activities of Quality Assurance, Basic Manufacturing Lab, Formulation Lab, Regulatory affairs, R&D and Validation.
• Has looked after the activities of plant (Basic manufacturing and Formulations)
• Responsible that the department must document its policies, procedures, specifications and methods to assure the quality of products.
• To manage the Quality Control Laboratory and make positive and energetic contribution in the improvement and consolidation of the total Quality Control system.
• To have a final check of batch manufacturing record and signing on GMP compliance certificate for its release to be sale.
• To monitor stability studies e.g. planning for taking stability samples, schedules of stability, review of stability results.
• Customer complaint handling, i.e. receiving, investigation, review of complaints and making comparative data of complaint.
• To monitor deviation in the batch / processes and its approval and recording.
• To coordinate with Procurement Department in conducting supplier audit / inspection and making its report.
• To look after the activities of validations.
Company industry:
Pharmaceutical Manufacturing
Job role:
Quality Control

Deputy Manager Quality Control

June 2005 - November 2007

PLATINUM PHARMACEUTICALS, Karachi, Pakistan

Karachi, Pakistan

June 2005 - November 2007

• To plan, allocate and control of all activities related to quality control of the starting material, packaging materials and of finished products.
• To release or reject starting materials, packaging materials (including final containers and labels) and products at intermediate stage for subsequent processing.
• Plan and assign daily jobs to the Analyst / Microbiologist for test and analysis of raw materials, packing materials, in-process samples and finished products.
• Coordinate with production department for timely release of raw, packing and finished products for smooth production.
• Justification and purchase of new instruments and chemicals required in the lab.
• Coordination with regulatory department for applying ministry requirements and sufficient documentation associated with it and also fulfilling the requirements of export documents.
• Checking of the documents related to ISO certification (17025 and 9001) needed to be updated.
• Designate Quality Control representative to check dispensing of raw materials.
• Designate Quality Control representative for in-process check.
• Ensure collection of samples as per sampling plan.
• Ensure that Good Laboratory Practices are being followed along with the training of personals working in the laboratory.
• Check that up-to-date results of test and analysis are being documented timely.
• Ensure timely preparation of Certificate of Analysis.
• Arrange stability studies of the products, planning for taking stability samples, schedules of stability, review of stability results and making comprehensive report of stability results.
• Arrange development of analytical methods for the test and analysis of semi-finished samples and finished products.
• Arrange the testing of process validation.
• Follow-up internal calibration of instrument and maintain proper record of Internal / External calibration of instruments.
• Conduct and maintain record of proficiency test.
Company industry:
Pharmaceutical Manufacturing
Job role:
Quality Control

Quality Assurance Officer/ Analyst

October 2002 - June 2005

ELI LILLY GOHAR & ALI GHAR PHARMACEUTICAL., Karachi, Pakistan

Karachi, Pakistan

October 2002 - June 2005

Analyst (Quality control Department)

• Responsible for the analysis of raw material, semi finished & finished goods.
• Responsible to prepare report of analysis of finished goods & Raw materials.
• Weakly analysis of distilled water.
• Analysis of expired product, market complain and drug inspector sample as assigned.
• Responsible for entries of all analytical data and results in respective files and register.
• Responsible to prepare reports/defect report of packaging material and its maintainance.
• Calibration of different instrument when required or assigned.
• Responsible for the preparation of all volumetric solutions test reagents and their proper labeling.
• Responsible to arrange the reference standard with their certificate of analysis and placing them in alphabetical order.
• Sampling of raw material semi finished, finished & packaging material when needed.
• Microbial contamination testing of Raw Materials and Finished Products.
• Microbial testing of Tap Water and Distilled Water.
• Area Monitoring (Environmental monitoring) of warehouse, manufacturing and packaging area.
• Finger dab test of workers, involve in manufacturing of products.

Q.A officer (Quality Assurance Department)

• Involve in in process controls of compression of tablets, filling of capsules, filling of injections (sterile area), cephalosporin area and packing of liquids as well as solid products on daily basis.
• Involved in validation activities
• PPQE (periodic product quality evaluation) record making.
• Monitor daily GMP-non-Compliances in production areas and store.
• Coordinate QA Head in conducting GLP inspection.
• Batch record checking before final release of finished goods for market.
• Give line clearance before start of compression, filling of capsules and packing of liquid and solid products.
• Verify the process of destruction of cartons, labels, finished goods waste etc.
• Dispensing of raw materials.
Company industry:
Pharmaceutical Manufacturing
Job role:
Quality Control

Incharge Pharmacy

July 2000 - April 2002

AL. ADWANI POLY CLINIC, Makkah, Saudi Arabia

Mecca, Saudi Arabia

July 2000 - April 2002

• Extemporaneous preparation of non sterile products like ointments, solutions and syrups based on prescription from physicians.
• Checking the prescription for any history of drug allergy, any specific drug interaction, pregnant patients and their medications and general precautions applied for any drug over dose or reaction
• Checking of prescription when dispensing process completed by assistant.
• Educate patient about dosage timings, administration and duration of treatment.
• Maintain patients data and drug profile.
• Checking of drug storage condition and expiry inside the clinic and pharmacy.
• Provide information of the drugs to the doctors and other paramedics.
Company industry:
Other Healthcare Services
Job role:
Medical, Healthcare, and Nursing

Analyst (Raw material testing Department)

October 1997 - July 2000

HOECHST MARION ROUSSEL (pvt) Ltd. (Presently SANOFI AVENTIS)

Karachi, Pakistan

October 1997 - July 2000

• Responsible for the analysis of raw materials and sterile product.
• Responsible for the analysis of packaging components.
• Responsible for the checking of Art Work.
• Responsible to prepare report of analysis of finished goods & Raw materials.
• Weakly analysis of distilled water.
• Responsible to entries all analytical data and results in respective files and register.
• Responsible to prepare reports/defect report of packaging material and maintain proper.
• Responsible to ensure the all volumetric solution test reagents, and their proper labeling.
• Sampling of raw material & packaging material when needed.
Company industry:
Pharmaceutical Manufacturing
Job role:
Quality Control

Education

Department of Pharma Chemistry, Faculty of Pharmacy, University of Karachi,

November 2005

November 2005

Doctorate, Pharmaceutical Chemistry

Pakistan

Research topic " Interaction studies of few Quinolone Anti microbial agents with essential and trace elements" PUBLICATIONS • Paper published on “Pefloxcainium methanesulfonate 0.10-hydrate” Acta. Cryst. C56, 910-912 (2000). • Paper published on “Enoxacin trihydrate” Acta. Cryst. C60, o281-o283 (2004). • Paper presented on “Erythromycin metal complexes” at 9th National Chemistry Conference at HEJ Research Institute of Chemistry and Department of Chemistry, University of Karachi (1998).

Dept. of Pharma Chemistry, Faculty of Pharmacy,University of Karachi

December 1997

December 1997

Master's degree, Pharmaceutical Chemistry

Pakistan

Research Topicic " Erythromycin metal interactions"

Faculty of Pharmacy, University of Karachi

December 1993

December 1993

Bachelor's degree, Pharmaceutics, Pharma Chemistry, Pharmacology, Pharmacognosy

Pakistan

GPA (point): 2.6 out of 4

GPA (point): 2.6 out of 4

Skills

Plant Operations
Expert
Plant Operations
Expert
Pharmaceutical quality control
Expert
Pharmaceutical quality control
Expert
Pharmaceutical Research
Expert
Pharmaceutical Research
Expert
Pharmaceutical Regulatory affairs
Expert
Pharmaceutical Regulatory affairs
Expert
MS Word, Excel, Power point
Expert
MS Word, Excel, Power point
Expert
Plant Operations
Expert
Plant Operations
Expert
Pharmaceutical quality control
Expert
Pharmaceutical quality control
Expert
Pharmaceutical Research
Expert
Pharmaceutical Research
Expert
Pharmaceutical Regulatory affairs
Expert
Pharmaceutical Regulatory affairs
Expert

Languages

English
Expert
Arabic
Intermediate
Urdu
Expert

Memberships

Saudi Commission of Health Specialties

For practice as a pharmacist (Registered Pharmacist)

November 2000

Pharmacy Council of Sindh

Membership

May 1994

Training and Certifications

Certifications
process development and validation
pakistan Pharmaceutical Educational Foundation
Mar 2006 - Mar 2006
“Lab management system, ISO 17025” from QMS 9000
Quality Management Systems. 9000
Mar 2010 - Mar 2010
GMP,GLP and GSP
World Health Organization in collabration with Ministry of Health Pakistan
Apr 2007 - Apr 2007
Internal and external quality control and traceability
Pakistan national accreditation council
Aug 2007 - Aug 2007
GMP, Quality control, Quality Assurance and manufacturing Technology
University of Karachi in collabration with Therapeutic product programme MOH canada
May 1998 - May 1998
leadership...from the inside out
Ace center for workplace spirituality
Apr 2010 - Apr 2010
the role of research and development in improving access to maedicines
institute of pharmaceutical sciences,UVAS,lahore
May 2010 - May 2010
Uncertainty of measurement in chemical and microbial testing
Pakistan national accreditation council
Aug 2007 - Aug 2007
“Development of the dossiers for submission to the WHO Prequalification Program
World Health Organization with the collabration of Ministry of Health Pakistan
Apr 2008 - Apr 2008
Advance course in X-ray crystallography
H.E.J research institute of chemistry,university of karachi
Dec 1998 - Jan 1999
basic life support provider
king khalid university hospital medical education department
Mar 2011 - Mar 2011
lead the change ....from inside out
Ace center for workplace spirituality
Aug 2009 - Aug 2009
Powerful public speaking and presentation skills
OCTARA
Oct 2009 - Oct 2009
training course on method validation
Pakistan national accreditation council
Aug 2007 - Aug 2007

Hobbies

  • Traveling, Book Reading