Career as Manager - CQA (formulation) in Titan Laboratories

Titan Laboratories Pvt. Ltd is EU-GMP Manufacturers of Sustained & Modified Release Pellets, DC Granules, Taste Mask Granules, Tablets & Capsule.

Post: Manager - CQA (formulation)

No.of post: 01

Job Description
1) Conduct the Self Inspection of the manufacturing site.
2) Regulatory Audit Compliance.
3) Vendor Audit. (As an Qualified Auditor)
4) Tracking of CAPA.
5) Conduct the GMP Inspection of third party manufacturing site.
6) Market complaint investigation.
7) Review of Technical Documents (Technology Transfer /Validation/Qualification).
8) Training.
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
Candidate should independently faced the audit of EU GMP,USFDA,MHRA.

Additional Information:
Experience: 8-13 years
Qualification: B.Sc, M.Sc, B.Pharm, M.Pharm
Location: Mahad,Raigad
Industry Type: Pharma
Salary: 12 lacs
Functional Area: CQA
End Date: 15^th December, 2016