Manager QA - Pakistan Pharmaceutical Products (Pvt.) Ltd.
(2019-01-01)
Joining this company 1st jan 2019 of Manager QA in Pakistan pharmaceutical Products(Pvt.)Ltd.
- Preparation and review technical transfer of protocol and reports.
- Ability to handle analytical method, cleaning and process validations.
- Handling of product complaints and providing CAPA for the same.
- Assist in Internal and External Quality Systems Audits and the CAPA implementation.
- Vendor evaluation and qualification for starting materials and raw materials.
- Preparation of Annual Product Review (APR).
- Logging and handling the investigations for deviations, OOS and providing CAPA for the same.
- Change control management.
- Provide support to the various divisions for effective and efficient implementation of the Quality Management System.
- Upgrade Quality Control process.
- Co-ordinate with Production, QC, warehouse and Maintenance regarding non-conformance & corrective action for the same
Manager QA - Maple Pharmaceutical (PVT)LTD
(2015-12-01 - 2019-01-01)
About 3 years' experience of manager QA in Maple pharmaceutical.
- Compilation of Local and Export Dossiers.
- Preparation and review technical transfer of protocol and reports.
- Ability to handle analytical method, cleaning and process validations.
- Handling of product complaints and providing CAPA for the same.
- Assist in Internal and External Quality Systems Audits and the CAPA implementation.
- Vendor evaluation and qualification for starting materials and raw materials.
- Preparation of Annual Product Review (APR).
- Logging and handling the investigations for deviations, OOS and providing CAPA for the same.
- Change control management.
- Provide support to the various divisions for effective and efficient implementation of the Quality Management System.
- Upgrade Quality Control process.
- Co-ordinate with Production, QC, warehouse and Maintenance regarding non-conformance & corrective action for the same
Deputy Manager QA/ Validation - Maple Pharmaceutical (PVT)LTD
(2008-12-01 - 2015-12-01)
- Managing validation planning.
- Managing Method Validation
- Managing Process Validation
- Managing Cleaning Validation
- Managing Validation sample collected.
- Managing Validation protocol.
- Managing Validation SOP,s.
- Managing Validation reports.
- Managing Validation testing
- Managing Instrument Validation IQ/OQ/PQ Protocol & Report
- Managing Validation of HVAC System
- Dossiers of local and export
- To maintain the quality manual
- To maintain the Quality management system
- To maintain Safety Manual
- Approval of all testing matter in QC(Finished Product
- Method Development of new product
- Responsible all QC and QA Matter
- Supervise of all Microbiological activity
- Preparation of stability product Protocol
- Responsible of SOP'S & report of APR
- Responsible of Collected Date APR
- Responsible of APR established annual schedule
- Responsible of APR reports maintain
- Responsible of CAPA activities
- Responsible of Change Control activities
- Responsible of NCMR report.
- Responsible of deviation activities.
- Responsible of Out of specification activities
- Responsible of Quality Control Budget preparation
- Responsible of trial batch and R&D work.
- Responsible of all QA & QC work
- Reviewing and up date of specification and SOP's
- Approved Art work and packaging material
- Responsible Internal audit of plant
- Procurement of equipment, chemical and other items preparation comprising sheet and purchase order.
- Responsible to order and maintain Inventory
- Management representative of ISO 2200:2008 and ISO 9001:2008
- Responsible of all documentation
- Like Site master file
- Quality manual
- Safety manual
- Environmental system
- GMP system
- Trial batch of soft gel
- Trial batch of Cranberry Sachet
- Trial batch of Tablet
- Trial batch of herbal syrup
Assistant Manager Q.C - Lexicon pharmaceutical private limited
(2004-01-01 - 2008-01-01)
Three years experience.
- Responsible of finished product
- Responsible of trial batch manufacturing
- Responsible of raw material testing
- Responsible of New Method development of new product
- Responsible Validation Activity.
- To plan and carry out stability studies of trial batches.
- To plan and prepare formulation and manufacturing for trial batches of new product.
- To plan manufacturing of trial batches.
- Registration of product for local, and export.
- To initiate and proof reading of art work for new products.
- Stability protocol
- Supervise of All Microbiological Activities
Senior Quality Control Analyst - Elko organization private limited
(2002-01-01 - 2004-01-01)
Three years experience.
- Analysis of finished product
- Analysis of all tablet testing process
- Analysis of solution
- Analysis of dry suspension
- Analysis of cream
- Analysis of ointment
- Analysis of powder
- Analysis of capsule
- Analysis of gel
- Analysis of raw material
- Perform the microbiological testing
- Perform the LAL test.
- Perform the Microbiological assay (finished and raw materials)
- Perform the pyrogen test.
- Check the calibration of instrument HPLC
- Check the calibration of instrument Spectrophotometer
- Check the calibration of instrument Disintegration apparatus
- Check the calibration of instrument Dissolution apparatus
- Check the calibration of instrument Friability apparatus
- Check the calibration of instrument P H meter
- Check the calibration of instrument Conductometer
- Check the calibration of instrument Potentiometer
- Check the calibration of instrument FT-IR
- Check the calibration of instrument Karl-Fischer
- Check the calibration of instrument Moisture Analyze
- Operate the MS office
- Operate the Internet
- Operate the Business Management System
