- To develop the company quality policy and new production development policy.
- To supervise over all activities of Q.A./ Q.C.
- To develop and implement internal cGMP/cGLP practices and ensure the compliance
- To review and approve all new product dossiers and documents for manufacturing e.g. BMPR, packaging order, specifications etc.
- To review and approve all process development program / protocol; stability program / protocol; modified process etc. for implementation.
- To review and approve all specifications, analytical methods, protocol / reports etc. for compliance as per regulatory requirements
- To review and approval of master validation program, including equipment's, processes, facilities, analytical methods etc.
- To investigate out of specification results or failure investigation related to testing or manufacturing etc.
- To investigate the customer complaints and product recall and initiate the remedial actions.
- To review and approve all deviations or non conformance related to quality systems and procedures and change control procedures.
- To identify the Quality Improvement Programs and ensure the compliance on regular basis
- To review and upgrade the quality systems as per the latest regulatory requirements on periodical basis.
- To evaluate quality performance indicators like Trend analysis on product quality, post market surveillance data, non-conformances etc. and initiate remedial actions.
- To review and authorize change control related to Quality Systems, Processes, Shelf life of products, etc
Perks and BenefitsBest in the Industry
Desired Candidate Profile
UG:B.Pharma - Pharmacy, B.Sc - Any Specialization, Chemistry
PG:MS/M.Sc(Science) - Any Specialization, M.Pharma - Pharmacy
Baroque Pharmaceuticals Pvt Ltd
Recruiter Name:Kalpit Darji
Contact Company:Baroque Pharmaceuticals Pvt Ltd
Address :192/2&3, 190/1 & 202/9, At. Sokhada, Tal. Khambhat, ANAND, Gujarat - 388620,India