QUALITY COMPLIANCE ASSISTANT MENA
BOEHRINGER INGELHEIM
Total years of experience :13 years, 3 Months
• Assist in implementation of Quality management system, Quality culture and its affiliates including product and quality compliance tasks etc.
• Assist in maintaining the policies and procedures for the general operations of QMS and Quality risk management etc.
• Full control on shipment release, quarantine and destruction process.
• Preparations of annual revision plan for local SOP.
• Ensure transfer of corporate procedures into local SOPs/WIs (maintenance, personnel training, documentation).
• Establish and maintain effective quality systems and SOPs in line with Boehringer Ingelheim requirements.
• Ensure GMP and regulatory compliance of products.
• Organization of telecom/video cons/ face to face meetings including agenda filing, protocol responsibility, task tracking with third parties.
• Preparation and maintenance of Quality assurance agreements (QAAs) for local third party suppliers (e.g. labs, warehouses, carriers, distributors etc.) to ensure regular review and revision if necessary.
• Responsible to perform Product Quality Review by analyzing batch records & trend evaluation of critical process parameters to draw statistically relevant conclusions. Summarizing product findings, highlighting risks and recommendations for Product Quality Review.
• Reviewing data for complaints, deviations, change controls, validation, packaging, stability, process capabilities, laboratory tests and regulatory status etc.
• Communicate risks highlighted to the all concern department with the follow up of the corrective and preventive action (CAPA) taken for continuous improvement.
• Investigation for Out Of Specification/Out of trend Results by preparing protocols for expanded investigation.
• Batch Record issuance according to plan.
• Monthly reporting of SMART Key Performance Indicators to senior management.
• Responsible to perform the line clearance, In-Process Control checks, continuous monitoring and inspection of the manufacturing, packing and ware house area to meet GMP and GSP.
• Preparation, review and check compliance of SOP's of QA functions. Conduct cGMP & SOP training as per training calendar.
• Granted expiry and printing approval for batch coding information at primary and secondary packing stages.
• Sampling of semi-finished and finished goods from manufacturing and packing areas respectively.
• Auditing of Batch manufacturing records. Auditing of batch packaging records with the relevant entries on system, dispatches and labeling in warehouse.
• Prepare cGMP anomalies, change control and deviation on SAP
• Responsible to perform the line clearance, In-Process Control checks, continuous monitoring and inspection of the manufacturing, packing and ware house area to meet GMP and GSP.
• Preparation, review and check compliance of SOP's of QA functions. Conduct cGMP & SOP training as per training calendar.
• To conduct calibration of In-Process Control lab equipment’s.
• On time reporting of IPC data for monthly reporting.
• Granted expiry and printing approval for batch coding information at primary and secondary packing stages.
• Sampling of semi-finished and finished goods from manufacturing and packing areas respectively.
• Auditing of Batch manufacturing records. Auditing of batch packaging records with the relevant entries on system, dispatches and labeling in warehouse.
• Prepare cGMP anomalies, change control and deviation on SAP.
• Responsible to perform Product Quality Review by analyzing batch records & trend evaluation of critical process parameters to draw statistically relevant conclusions. Summarizing product findings, highlighting risks and recommendations for Product Quality Review.
• Reviewing data for complaints, deviations, change controls, validation, packaging, stability, process capabilities, laboratory tests and regulatory status etc.
• Communicate risks highlighted to the all concern department with the follow up of the corrective and preventive action (CAPA) taken for continuous improvement.
• Investigation for Out Of Specification/Out of trend Results by preparing protocols for expanded investigation.
• Batch Record issuance according to plan.
• Monthly reporting of SMART Key Performance Indicators to senior management.
I Worked in Abbot Laboratories (Pakistan) in manufacturing and quality control department as an internee from May 26, 2008 to June 22, 2008.
• Masters in Business Administration, Marketing (CGPR.3.4), 2013. Bahria University, Karachi campus. Prepared a dissertation for the completion of MBA program on SUGGESTING A NEW BUSINESS MODEL FOR GETZ PHARMA in 2013.
• Secondary School Certificate, Science (83.4%), 2001. Shamsi society model school, Karachi.
MAJORS: Pharmacology pharmacognosy pharmaceutical chemistry pharmaceutics ACHIEVEMENTS: I achieved four (4) Gold Medals during Pharm-D program, two (2) for securing First Position in Doctor of Pharmacy (Pharm-D) 2010, one (1) medal for Best Graduate 2010 and one (1) for securing Highest Marks in 2010.
• Higher Secondary Certificate, Pre-Medical (71.4 %), 2003. B.A.M.M PECHS Govt. College for women, Karachi.