Profile – Quality Head
Preferred Industry - Pharma
Location – Bahadurgarh
Salary – Up to 25 LPA (Depends On Interview)
Qualification – MPharma/MSc
Experience – 15 Years (Min 5 years in USFDA Plant)
Key Responsibilities -
* Monitor the testing and Release of Raw materials, In-process, and finished products in the stipulated time.
* Sample management of RM/PM/in process/FP.
* Monitor stability sample testing and preparation of stability report.
* Preparation of AMV protocol and report.
* Responsible for routine release of swab and rinse water analysis.
* Responsible for HPLC operations.
* Responsible for preparation and implementation of qualification/calibration schedule.
* Responsible for preparing/updating STS/STP/worksheet/COA of RM, PM, In process.
* Preparation and maintenance preventative maintenance (AMC) and calibration calendar.
* Maintain the laboratory in good condition to face regulatory audits.
* Responsible for Calibration of all QC instruments.
* Responsible for following related SOPs.
* Job Allocation of QC persons.
* Initiation and closing of QMS documents like Out Of Specification, Change Control, Deviations, CAPA, Incidence report, etc.
* Facing the Internal/External audits.
* Responsible for Analyst qualification and training.
* Responsible for the completion of log books.
* Procurement of Chemicals/Reagents/Reference standards/impurities and maintain the inventory.
* Responsible for timely review of the raw data generated in the Quality Control Laboratory.