Sun Pharma is the fourth largest specialty generic pharmaceutical company in the world. We provide high-quality, affordable medicines trusted by healthcare professionals and patients in over 150 countries. It is also India's largest, most trusted and most valuable pharmaceutical company by market capitalization.
Post : QA Head
Job Summary
QA Head (Quality Assurance Head) is a leadership role responsible for ensuring the quality and safety of all products and processes, adhering to Good Manufacturing Practices (GMP) and regulatory standards, and overseeing the QA team
Areas of Responsibility
1) Expertise in qualification of below process and equipment’s: To aware about the process like vial washing, depyrogenation, filtration, filling, manufacturing, lyophilizer, component washing and sterilization, terminal sterilization, isolators, CIP SIP skid, leak test, X ray inspection, VHP, clean utility like steam, compressed air, PW and WFI generation system, AHU, FFM
2) To handle the designing and reviewing of qualification activity of process equipment’s like vial washing, tunnel sterilizer, filling machine, capping machine, Lyophilizer loading and unloading system, Lyophilizer, filtration skid, and isolators, VHP passbox, manufacturing skid, suspension manufacturing skid, CIP SIP skid for manufacturing and filtration equipment’s, dispensing isolators, manufacturing isolators, pH meter, DO meter, integrity tester, Autoclave, Terminal sterilizer, ultrasonication machine, GMP washer, external washing machine, leak test and X ray inspection machine, packing equipment’s etc.
3) To handle the designing and reviewing of qualification activity of Utility like Pure steam generation and distribution system, Purified water and WFI generation and distribution system, Nitrogen and compressed air generation and distribution system, AHU, FFM, LAF, area, cold storage etc.
4) To review qualification protocol of new equipment like, User requirement specification, Design qualification, Installation qualification, Operational qualification, performance
- qualification and Computer system validation and qualification.
- To ensure compliance to cGMP and documentation for various production activities.
5) To review new standard operating procedure for qualification activity and also review SOP of process equipment’s.
6) To review schedule for qualification activity, calibration activity, updation of status label of qualification activity etc.
7) To review the QMS documents like change control, CAPA, risk assessment, deviation etc.
8) To involve during communication with vendor and procurement team on procurement to design parts of new equipment’s along with operation and CFT.
9) Ensure proper planning, execution of the qualification activity in accordance with the plan and allocation of man power
10) Exposure of regulatory auditors like USFDA, EU, ANVISA, CANADA etc
Candidate Profile
B. Pharmacy, M. Pharmacy.
Technical Skills/Competencies (Software packages, experience with specific machines etc.)
Excellent communication skills, strong collaborator, problem solving, interdepartmental coordination, team leadership.
Experience : (15 to 17 Years of experience in relevant field in Pharmaceutical Industry.)
Age : 37-42 years
Location : Central or South India (Greenfield Project)
How to Apply: Find below url which will redirect on Sun Pharma's career portal.
Apply Online for Sun Pharma QA Head >>
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