Urgent requirement for the post of DGM-QA (1 post) & Asst. Manager-QA (2 posts) for a reputed pharma company in Mumbai (job location: Raigad)
Designation: 1. DGM - QA (1 Post), & 2. Asst. manager - QA (2 Posts)
Job Location: Raigad
education: B.SC/M.SC/B.Pharma, M.Pharma
Experience: 7 yrs and above
Industry: Pharmaceuticals ( Formulation)
Function Area: Production
Key Skills: Formulation Experience Only
Salary Range: 5.0/- to 10.0/- Lacs pa.
1 Manufacturing of Sustained & modified release, Pellets, DC granules, Taste mask Granules, Tablets & Capsules.
2 Should have faced and cleared MHRA, USFDA, FDA).
3 Review of Technical reports for process evaluation batches (optinization) & planning of feasibility, scale-up & exhibit batches.
4 To provide inputs in the product development briefs on the technical feasibility.
5 To perform DQ, IQ, OQ, & PQ of equipments & to performing process validations & cleaning validations.
6 To ensure vendor qualification on time & also responsible for compalicance of various cGMP monitoring tools like internal quality audits, in process testing, line clearance etc.
7 To responsible for reviews & timely submission of various documents (MFR, BMR, BPR, validation reports ) & prepration & approval of Annual product reviews.
8 To ensure compliance of in process checks, sampling & daliy monitoring records.
9 To prepare & maintain SOP, Process validation equipments/Instrument qualification, protocl data compilation, monitor routine, calibration checkks & qualification reports.
10 Options of manifacturing sites, available technologies, PTS, opportunities relevent for the introduction of new products/Packing introduction.
11 Training to workman and Junior staffs.
Interested candidates shall send across their updated CV (word format) at firstname.lastname@example.org