Manager Quality Assurance
Herbion pharma
Total years of experience :12 years, 4 Months
➢ Quality Management: Implement and maintain a robust quality management system in compliance with
local and international pharmaceutical regulations, including cGMP (current Good Manufacturing Practices).
➢ Regulatory Compliance: Stay updated on changes in regulatory requirements and ensure the company's
operations and products are in compliance with local and international quality and regulatory standards,
such as the Pakistan Drug Act and DRAP regulations.
➢ Quality Control: Oversee the quality control processes and systems, including incoming raw materials, inprocess checks, and finished product testing to maintain high-quality standards.
➢ Audits and Inspections: Prepare for and manage regulatory audits and inspections by local health
authorities or international regulatory bodies. Ensure corrective actions are implemented as needed.
➢ Documentation: Maintain accurate and up-to-date quality-related documentation, including batch records,
SOPs, and validation reports, and ensure they meet regulatory requirements.
➢ Team Leadership: Lead and develop the QA team, providing guidance and training to ensure a high level of
competence and a culture of quality.
➢ Quality Improvement: Continuously identify areas for quality improvement and implement strategies to
enhance product quality and process efficiency.
➢ Risk Management: Identify and mitigate potential quality risks and deviations through proactive problemsolving and root cause analysis.
➢ Vendor and Supplier Management: Evaluate and monitor the quality performance of suppliers and vendors,
ensuring they meet our quality standards.
➢ Communication: Maintain effective communication with cross-functional teams, including R&D, production,
and regulatory affairs, to ensure alignment with quality goals and objectives.
➢ Projects:
❖ cGMP Audit by Health Canada
❖ Uzbekistan Health agency, Govt. of Uzbekistan
❖ Ministry of health of the republic of Belarus
❖ DRAP DML & GMP certification audit
❖ Risk Based Inspection by DRAP
❖ ISO-9001: 2015 Certification
❖ Registration and launch of products (VOCAB, Synjard, Synjard-Met, SGP, SGP-Met)
❖ Revamping project for Solid preparation Section.
❖ Facility design project for personal care Section
Ensure Quality Culture & good manufacturing practices.
➢ Ensure day to day Activities are aligned as per Plan.
➢ Ensure that all Quality Management functions such as Change Management, Quality Risk Management,
Product technical complaints, Documentation Control, Deviation Management, OOS/ OOT Management,
and CAPA are developed, implemented, maintained with continual improvement.
➢ Provides guidance and coaching to Quality Operations colleagues and provides direction of activities and decisions
➢ Ensure APQR program and ensure that recommendation made in Annual Product Quality Review have been
implemented.
➢ Ensure that products batch records are effective/ thoroughly audited before release as per approved
procedure.
➢ Ensure plant is designed & developed (New/ Renovation) as per regulatory/ cGMP requirements.
➢ Ensure that plant layout, personnel flow, material flow, air schematics, utilities flow drawings & area zoning
drawings are available.
➢ Ensure that Site Master Validation plan is in place and implemented.
➢ Hands of experience on cleaning validation, process validation, equipment qualification.
➢ Ensure that Vendor/ Service Provider Qualification Program developed, implemented, and maintained.
➢ Ensure required competent personnel are available to conduct QA/Validation activities.
➢ Support to arrange Management Review Meeting as per defined period.
➢ To ensure internal audit is carried out in pre-defined interval.
➢ Implementation of quality management system i.e. Change Control, Deviation Process, Out of Specification
/ out of trend: Maintained and implement the records for the same and information to various
department/authorities.
➢ Evaluate, conduct gap analysis & update QMS functional documents in accordance with MHRA Guidelines &
MHRA UK Consultant.
➢ Review and timely execution of Master documents likes Validation Master Plan and Site Master File,
Preventive Maintenance Plan and SOP.
➢ Lead Quality Risk Management at the site and ensure that an effective Risk Management system is in place
in accordance with Quality Standards.
➢ Lead APRR program and ensure that recommendation made in Annual Product Record Review have been
implemented.
➢ Lead Document Management System and ensure timely issuance of compliance documents to relevant
stakeholders.
➢ Manage multiple projects and ongoing work activities within the division typically involving cross- functional
representatives.
➢ Provides guidance and coaching to Quality Operations colleagues. Provide Quality Assurance expertise to
site and external parties as required.
➢ Identify continuous improvement opportunities based on metrics and drive consistency through the process
to align with standard processes and quality systems.
➢ Take independent actions and decisions and motivate key stakeholders to deliver quality outcomes for
business requirements.
➢ To review batch manufacturing record after compilation of manufacturing activity and test records from
Quality Control are received and available for released the product.
Technical Expertise:
Pharmaceutical Quality Management System
Good Manufacturing Practice
Good Laboratory Practices
Good Documentation Practices
Regulatory compliance
ISO 9001:2015 (TUV Austria)
ISO/IEC 17025:2017
(Successful Pre Assessment and Post Assessment Audit)
Validation
Data Integrity and compliance
Training Management
Quality Risk Management (ICH Q9)
Internal Audit
Advance Excel and Office tools
SAP (EHP 7.0)
Power BI (Data Analytics & Visualization)
ICH Guidelines (Q1, Q2, Q3, Q4, Q6, Q7, Q8, Q9, Q10)
HPLC LC 10, LC 20 LC2030 Prominence-I (Isocratic) (Gradient)
UV Spectrophotometer (Shimadzu 1600/1700)
IR Spectrophotometer
Dissolution Apparatus (Pharm-test/DISTEK)
Disintegration Apparatus (Copley UK)
Hardness Tester
Friability Tester
Karl Fischer Apparatus (Met Rohm\Mettler)
Potentiometer (Mettler)
Polarimetry
Refractometer
Melting Point Apparatus
Moisture Analyzer
Conductivity Meter
pH Meter
Viscometer
Analytical Balance
TOC Analyzer
UV Cabinet
Handling of TLC Apparatus
Quality Control (Finish product Section)
To perform Analytical Testing for Bulk/semi-finished/finished products/Stability Products/source
change Finished products/Process validation Samples.
• To ensure that GLP is adhered for testing through the following laboratory procedures.
• Schedule maintenance and calibration program
• Ensure compliance of EHS policies and procedure and Confirm reporting to EHS and the management for any near miss/ZAP, incident or accident.
• Enter Results in SAP for finished products.
• To trouble-shoot when there any analytical problem and recommend solutions.
To recommend and highlight to Section Head and QC Manager on methods to improve daily
laboratory functional system.
To ensure Laboratory Quality system are adhered to the following,
• Products meet or exceed customer expectations.
• Emphasis is on problem prevention rather that detection.
• Root causes of the problem are found and effective corrections are made.
• Constant improvement of the product and testing procedures are enhanced.
To perform any other task as assigned by Section Head or QC Manager.
To inform Section Head /QC Manager for all non-conformance or any issue or problem
related to Quality Laboratory immediately.
Technical Expertise
1 Method Validation/Verification.
2 Comparison Dissolution Profile (CDP).
3 Cleaning Validation
4 Audit Trail review/Data Integrity and compliance
5 ISO-17025:2017 awareness training
6 Corrective Action and Risk Assessment
7 OOS, OOT, Deviations Management.
8 SOP/Testing Method/specifications Preparation.
9 GMP Document System and Record Management
10 Standardization and control of Samples.
11 Instruments Control & Calibration
12 Performance Qualification of instruments.
13 Stability Studies Programs
14 QC Services and purchase of supplies.
15 Vendor Registration & Audit and Supplier Evaluation (Lab Equipment)
16 Lab Inventory Management
17 Measurement Uncertainty Calculations.
18 Blind Sample/PT Sample Testing
19 Lab Facilities equipment & utilities Proper operational control system
20 CAPEX & OPEX
21 LIMS Stability Module
22 SAP (System Application Products).
Support QMS
Validation
Calibration Of instruments
Handling Of Finish and Bulk Products
Raw Matrial Analysis
Packaging Matrial Analysis
Finished Product Analysis
Raw Material Sampling
Log books and Note books review
Follow up GMP & GLP and SFDA rules.
TECHNICAL INSTRUMENTS HANDLING
• HPLC LC 10, LC 20 (Isocratic & Gradient)
• UV Spectrophotometer
• IR Spectrophotometer
• Dissolution Apparatus
• Disintegration Apparatus
• Hardness Tester
• Friability Tester
• Conductivity Meter
• pH Meter
• Viscometer
• Karl Fischer
• Analytical Balance
• Polarimeter
• Refractometer
• TOC Analyzer
Regulatory Affair Control
• Dossiers preparation for registration & renewal for submission to local regulatory authorities.
• Archiving & record keeping.
• Maintenance of DMF, CAPEX, External SOPs Record.
• Responding time to time queries as raised by drug inspectors & drug testing laboratories.
• Solving Export Queries for the regulatory Compliance.
• Correspondences for approvals, changes, intimations for regarding packaging, source of raw material, transfer of registrations.
• WHO Dossier Preparation.
Quality Control (Stability Study Section)
• Independently performs pre-stability/ GMP stability testing and all other analytical related activities including new trial Batches (P.D Products.)
• Perform all laboratory work with proper planning and scheduling of jobs.
• Follow CGMPs GMPs, SOPs, HSE requirements and other applicable regulations.
• Review laboratory notebooks (routine testing).
• Execution of Pre-stability / GMP Stability samples and maintenance of laboratory database.
• Train associates on analytical methods and instrumentation case by case basis.
• Keep abreast on the latest changes in analytical science with limited supervision.
• Write / Review SOPs, qualification documents and protocols
• Participate in project teams and assist in troubleshoot and finding solutions.
• Conducts experiments, investigations, and special testing as needed for problem solving, to address regulatory issues, or to characterize drug substances/ drug products.
• Work closely with members of cross functional teams at different locations.
• Maintains GMP compliant, state-of-the-art analytical laboratories.
• Follow up ICH, WHO, FDA, DRAP Guidelines.
Quality Control (Packaging Study Section)
• Packaging material Testing.
• Proof reading of product leaf inserts & other packaging components to assure
Compliance with drug labeling& packaging guidelines.
• Maintain Records of Packaging Material.
• OOS Specification
• Releasing of All packaging Materials.
• Art work checking & approval after considering regulatory basics.
I am a Registered Pharmacist.
URL removed due to policy violation. Please contact support for further information.