Senior Executive Quality control / Quality standard specialst
BAHRAIN PHARMA
مجموع سنوات الخبرة :14 years, 9 أشهر
• Coordinate with Quality Control Analysts, Microbiologist, examiner and other staff and provide them written procedures for Analysis, Examination and other Quality control test to control the quality of the products produced.
• Responsible to ensure that all quality control tests and documentation is in accordance with cGMP and other GLP requirements.
• Responsible for the development and modification of analytical control process of starting materials, intermediate products, and finished products in coordination with Quality Assurance Department.
• Responsible for the product validation of method of manufacture, equipment, instrument and cleaning procedures in coordination with Production, Engineering and Quality Assurance department.
• Responsible to maintain the Quality control records of reprocessing and recall products which meet all specifications and other quality criteria for its acceptance and release.
• Responsible for the preparation of budget to plan CAPEX, OPEX and inventory control of chemicals, glass wares.
• Thoroughly know the regulatory requirements of the local NHRA (FDA), describes the manufacturing of pharmaceutical products and cosmetics.
• Experience and expertise in Quality management system GMP, GHP
• To make sure the trending of finished products and critical incoming material and appraise management for any abnormal behaviour.
• Review the layout to ensure the laboratory infrastructure remain updated and sustainable to meet the operation requirements.
• Thoroughly knowledge of legal requirements to govern the mfg., export and import of the products and medical devices.
• Planning the incoming, intermediate (Semi finished) and finished products sampling, analysis and Release of Products, Raw materials in LIMS (Laboratory information management system) and BPCS (Business Planning Control System).
• Conducting Audits, Preparation of audits reports (CAPA preparation).
• Responsible for the timely completion of laboratory investigation & CAPA in coordination with the Quality Assurance.
• Cleaning validation and verification testing by HPLC
• Conducting GAP analysis of local procedure against revised GQP (Global quality policy) or GQMP (Global quality mandatory policy).
• Cross contamination study (swab test activity) by HPLC
• Analytical test methods developments and validation
• Preparation of technical rationale.
• Preparation of STP for risk to be entered in RMS (Risk management system)
• To make sure the timely calibration and maintenance of the laboratory instruments in line with approved procedure.
• Highlighting the risk and their mitigation plan accordingly.
• Preparation of validation protocols, validation reports and validation review reports
• Quarterly trending of products to ensure data integrity for the product quality.
• Ensure that the Laboratory related processes are described in SOP and are part of local QMS
• Responsible for the Laboratory compliance with internal and external regulatory requirements
• Experience in manufacturing environment, to coordinate, liase and work.
• Responsible for the updating documents in line with global quality policies (GQP) and global quality guidelines (GQG) through effective documents managements system.
• Expertise in statistics in quality assessment and problem solving tools like risk analysis, fish bone, 5 why.
• SOP's, IFS and TM Preparation.
• Conducting GLP, GMP trainings to make sure the training of laboratory staff in line with job requirements and internal procedure requirements.
• To plan and coordinate the sampling, analysis and release of the incoming, semi-finished and finished product.
• To recommend, plan, monitor and control the laboratory budgets (CAPEX and OPEX)
Do batch documentation check and BPCS documentation of Bulk and Raw materials.
Ensure products are tested and reported as per GSK Specifications and standards.
To test all SKUs (Stock keeping unit) of Augmentin products.
Report all results in LIMS (Laboratory information management system).
Punch documents in BPCS (Business Planning and control System).
To test the water pH, TDS and conductivity by conductivity meter.
To test bulk, intermediate and finished products of all strengths of different products in Antibiotic (Augmentin, Amoxil, Ampiclox, Orbenin, Penbritin and Princimox products).
To test impurities testing on all Augmentin products
Reporting OOS/atypical results to manager.
Revised, Separated and updated the IFS and test methods of Raw materials.
To sample all raw materials of Penicillin
To test all raw materials of Penicillin
Do BPCS transactions of Raw materials RTS, Dry materials into System.