We are hiring for Manager -CQA in reputed pharma company, Usfda Approved plant.
Post: Manager - CQA
No.of post: 05
Job Description
1) Candidate should independently faced the audit of EU GMP, MHRA, USFDA.
2) Conduct the Self Inspection of the manufacturing site.
3) Regulatory Audit Compliance.
4) Vendor Audit. (As an Qualified Auditor)
5) Tracking of CAPA.
6) Conduct the GMP Inspection of third party manufacturing site.
7) Market complaint investigation.
8) Review of Technical Documents (Technology Transfer /Validation/Qualification).
9) Intimate site QA in case of any change / addition / deletion / updation notification received from Vendors.
10) Coordinate with Regulatory, ADL and R&D, site QA, Purchase and other departments in case of Vendor Related Queries.
11) Check site / department compliance to all GMP activities through VMP, APQR, SOP and other QMS tools.
12) Review MFR, PDR of Projects prior to be transferred at site against R&D LNB's and other raw data available.
13) Execute Vendor Approval Procedure as per SOP for New Vendors.
Vendor Sample & Documentation Review, Schedule Preparations, Satus updation as per Regulatory Market / Customer requirements, Stability Data
14) Review in case of New Vendor materials batches.
15) Review important GMP and GLP SOPs at site to update as per changes in regulation or standard/current GMP and GLP Practices.
16)Identify GMP, GLP & Vendor Management relevant guidance documents, international guidance, new updates / Revisions in Monographs / Pharmacopoeias and provide interpretive assistance to relevant departments at Site, R&D & HO for procedure updation accordingly.
Candidate Profile
Should independently faced Audit EU GMP, MHRA, USFDA. Should have experience of formulation in Tablets, Capsules and pelletes Good Stability in current company Good communication skills
Additional Information:
Experience: 10+ Years
Qualification: M.Pharm/B.Pharm
Location: Ghatkoper, Mumbai
Industry Type: Pharma
Functional Area: CQA
Salary: 12 L - 15 L
End Date: 28th December, 2016
If you are interested then send your updated CV on- hr1.nurture@hotmail.com with following details Total Experience- Current CTC - Expected CTC- Notice Period - Team Size -
Posted by,
Pooja,
Nurture Consultancy
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