Compliance Senior supervisor
Klybeck Lifesciences
مجموع سنوات الخبرة :9 years, 8 أشهر
✓ Supplier Qualification & Management
• Vendor evaluation and qualification for raw materials and
Packaging materials (Primary and Secondary).
• To ensure the updating of Approved supplier list in a periodic basis.
✓ Handling of QMS
• Change control management: Evaluation, approval and scientific disposition of
changes with impact assessment from quality and regulatory perspective.
• Conducting investigations to identify the possible root cause for any Deviations/Incidents/OOS
from written procedures, assessing the impact of the deviation and identifying Corrective actions
act and Preventive actions (CAPA) to prevent recurrence and occurrence of the deviation.
• Investigation of complaints & recalls.
✓ Self Inspection
• Preparation of Annual plan for self Inspection.
• Execute inspection as per schedule covering all the departments.
• Preparation of Compliance report and follow up until the report is closed.
✓ Risk Assessment and Risk Management
• Performing Risk assessment studies for the processes and systems and preparing plans for
mitigating risks with by using Risk management tools like Fish bone (Ishikawa) & FMEA.
✓ In-process Quality Control Oversight
JOB DESCRIPTION .
Work starting permissions before starting the manufacturing and packaging processes of locally manufactured products (Tablets, Semi-solids and Parenteral) in various sections of production department after proper checking as per laid down procedures.
In-Process control testing during Manufacturing / Packaging and perform Regular and periodic IPQC checks to assure that Manufacturing & Packaging is carried out in accordance with the cGMP and laid down Bayer standards.
Physical testing of Imported finished products received from Bayer group as per laid down Standards, recording & recommending their release / reject status and to counter check master Batch Record of locally manufactured finished products and entering the release / reject status in the ERP system (Bay4S).
Report and Record the deviation and follow-up of CAPA at the plant to ensure implementation of changes after approval.
Dispatch Govt. health departmentcorrespondence.
Ensure compliance of different environmental parameter (e.g temperature, humidity, viable and non-viable monitoring) of production, ware-house & quality control department and to carry out dust sampling during different stages of manufacturing processes.
Ensure HSE, cGMP and GLP compliance and proper housekeeping at the plant.
Participate in execution of the qualification and validation activities assigned by QA Manager & QA head with proper documentation.
JOB RESPONSIBILITIES .
Monitors drugs manufacturing activities in compliance with the requirements of cGMP.
Ensures compliance of approved SOP and Bayer standards during production / packaging operations.
Ensures the general cleanliness and hygienic conditions of the manufacturing areas.
Ensures that all production equipment’s are maintained in good working order.
Ensures that there is discipline and good working culture among the staff.
Makes sure the on job training of production personnel.
Ensures the hygienic condition of production personnel.
Ensures production people wear mask, gloves and shoes before entering into production.
Sampling and Record retention of stability and Reference Samples.
GMP Record retention.
Performs other duties as assigned by QA/QC Manager.
Responsible to keep all confidential matters secret and protect the interest of the company.
Line Clearance of Dispensing of all the Raw materials of a Batch.
Right First Time “Line Clearance” for all the production processes to proceed.
Perform In-Process Quality Tests such as Moisture analysis of powders and granules,
Disintegration, Friability, Weight variation, Thickness and Hardness of Tablets and Viscosity, Density & pH measurements of Oral Liquids, Syrups, Suspensions & Topical creams. Leakage Test for Primary Packaging Materials e.g. Bottles and Blisters.
Ensures the general cleanliness and hygienic conditions of the manufacturing areas.
Ensures that all production equipment’s are maintained in good working order.
Ensures that there is discipline and good working culture among the staff.
Makes sure the on job training of production personnel.
Ensures the hygienic condition of production personnel.
Sampling and Record retention of micro, bulk, stability and Reference Samples.
GMP Record retention.
Performs other duties as assigned by QA/QC Manager.
Responsible to keep all confidential matters secret and protect the interest of the company.
A process-oriented and, results-driven Quality Control Inspector who has a passion for excellence. Experience of working on the production of a wide variety of manufactured goods and possesses a successful track of determining whether products meet expected standards.
لقد تم حذف الرابط بسبب انتهاكه لسياسة الموقع. يرجى التواصل مع قسم الدعم لمزيد من المعلومات.