Sr.Quality Assurance Pharmacist
Riyadh Pharma
مجموع سنوات الخبرة :17 years, 3 أشهر
• Good Management skill in handling of Quality systems like Quality Risk Assessment, Deviations, Change Control, Customer/Market Complaints, Vendor development, Return Goods, Recall, Documentation Control, Self Inspection, PQR, Batch Release, CAPA etc
• Experience in handling of Regulatory Audit / Inspections like IMB, Saudi FDA, MOH from GCC countries, Pakistan MOH and MHRA and Customer Audits like Abbott, Merck, Norgine, Smith & Nephew, Janssen Cilag, Mylan etc.
• Review third party agreements, and amendments to internal policies and procedures.
• To monitor and to train QA officers for effective implementation of Batch Release,
Vendor Qualification procedures for API, Excipient, Packaging Materials and General Compliance Activities.
• Member to perform Vendor Site Audit, Successfully Performed vendor site Audit, Completion of all documents for site audit and prepare vendor site audit report to QA Manager.
• Review Validation protocol, data sheets and its execution Reports.
• Prepare and submit Quarterly and Annual GMP Non Compliance Report to QA Manager
• Final review of BMR & BPR before QA manager approval and monitor Batch Release in ERP and in IBRCS.
• Handling of deviations, CAPA generation and its followup for effective implementation of corrective/preventive actions, assess the impact in quality of each deviation prior to the final decision of the QA Manager.
• Prepare plans for Pharmacopeial Updation, Self Inspection, Vendor Site Audit Schedule, APQR, Various Trend Analysis and monitor the data collection for the completion of eCTD preparation
• Review APR and issue CAPA if required.
• Perform visit and also conduct Self Inspection, in all production areas, Solid, Liquid, Semi Solid & Sterile lines also at Laboratories and Warehouses.
• Review of MF, BMR, BRP, AR, Shelf Life Spec, Texts, Artwork and other critical documents.
• Training sessions conducting for subordinates and other Technical Department in Quality System SOPs, GMP requirement and GDP as per schedule.
• Very Good Application knowledge on all responsibility in ERP, key member in coordinating with IT for incorporating ERP in Quality System, assisted in developing mre than 45 Quality Reports from ERP.
• Roll to assist the Project Manager in implementing eQMS in Riyadh Pharma (Performing eQMS Computer Validation )
• Reporting to -Compliance Manager.
Duties & Responsibilities
•Expert in reviewing Batch Manufacturing Records BMR, BPR QC Analytical data reports (Raw Material, Blend Uniformity Analysis/In-Process, Finished Product), with reference specifications.
•Preparation of Process validation Protocols and summary reports based on the Analytical results and Batch documents data.
•Preparation and Approval of Standard operating Procedures.
•Submission of data to IBRCS (Importing, Batch-Release & Clearance System (IBRCS) Beta.
•To co-ordinate the Qualification / Validation of the Equipment, Systems and Process.
•Documentation and review of Master Specifications for (Raw Material, Packaging Material, Finished Product ).
•Responsible for the IPQA of external line creams, ointments, solutions, liquid and also lotions.
•Good awareness with CTD and have reviewed all modules before Submit new files for SFDA .
•To ensure the preparation, Issuance, Revision/Review and Retrieval of the documents.
•To investigate the cause of any non conformance and its corrective / preventive action. Handling of Out Of Specification batches, investigation, reprocessing and related documentation as per cGMP requirement.
•Daily involvement in the planning activities of Production, Quality Control, Quality Assurance, In-Process lab, Marketing, Logistics and Market Complaints.
•Exert in completing and verifying IQ, OQ, PQ and DQ for all machines used in factory with requirements of equipment Calibration & Maintenance.
•Has good knowledge about GMP, ICH, 21CFR211 guidelines, Pharmacovigilance, and Regulatory Affairs.
•Completion activity of BMR, BPR and final review and approval for submission.
•Annual Product Quality Evaluation.
•Worked with Barcode, Pharmacode designing and review standard specifications.
•Daily monitoring of Humidity, temp and differential pressure at different areas.
•Daily monitoring of water station, retained sample room and stability chambers.
•Reporting Officer : QA Manager
• SDS Creation in accordance with the Regulation (EC)No 1907/206(REACH).
• Supplier SDS handling and interpretation of pharmaceutical Raw materials
•SDS creation and exposure assessment of raw materials in the pharma industry
•CLP Regulation (for "Classification, Labelling and Packaging") of raw materials according to the UN GHS(Globally Harmonised System).
•Meetings with engineers and program managers in USA over the phone, for various technical issues.
•Hazard assessment and classification of pharmaceutical raw materials according to different regulations.
•Calling to KOLs (Key Opinion Leaders) and Top Physicians in clinics with Detailing, Sampling, & LBLs.
•Conducting CMEs (Continuing Medical Education), Get together parties, Conference and Seminars.
•Arranging Patient Care Management program and counseling programs.
•Business generation thru tenders in Govt. Institutions & Corporate Hospitals.
•Organise Stall in Medical Colleges, Institutions & various conferences.
•Arrange Diabetic Camps, Medical Camps, Rural camps with top KOLs.
•Advertisement through Banners, Stickers and Posters has been set the benchmark.
•Market Research has been done both quantitative and qualitative.
•To do Competitor Intelligence for findings like prescribe, rate of prescription, brand prescribed and availability of product at chemist shop were regular profile.
•Benefits of bulk purchasing/deals canvassed well to intermediaries to improve sales.
•Checking shelf life, maintaining FIFO-FILO & stocks at all the intermediaries.
•Performing closing, making collections at all level at zero outstanding
•Order taking & order processing on fortnightly basis at stockiest and C & F.
CAREER SUMMARY •8 years of experience in Life Science Industry. •6+ years of Experience in a Saudi Pharmaceutical Manufacturing Industry ,currently working as Sr. QA Compliance Officer ( Acting Supervisor ) •Have faced licensor audit from Novartis, Merck, Norgin Pharma, Janssen Pharma , Mylan , and regulatory audit from IMB Audit and SFDA. •Key member in performing computer validation and its effective Implementation of computerized QMS Software in ( Nova LIMS QMS ) in Riyadh Pharma •In depth understanding of raw material, intermediates used in the manufacturing process and methodologies being practiced in industry •Expert to ensure compliance in all areas of drug manufacturing facilities of Ointments, Creams, Lotions, Liquids , Solids ,Sterile Preparations and Lotions. •Good sounded knowledge in SFDA regulation and GCC guidelines. •Effective time management and good ability to manage competing priorities •Learn and apply new technologies to meet market requirements. •Good understanding with cGMP ,21CFR Part 210 & 211 , ICH Q7 guidelines, SFDA and GCC Regulatory Requirement for drug registration in eCTD format and also PSUR. •Good attitude , analytical and statistical problem solving skills. •Excellent functional knowledge in ERP , Production Module , Inventory Module and Quality Module. •Excellent knowledge in , Access and Microsoft Office , Excel and PowerPoint