QC

Experience in Documentation, Issuance, CCF, Trackwise, SOP preparation, well versed with GMP and Regulatory requirements of USFDA, EU, ANVISA, AQA.

The applicant must have experience in pharma units approved by regulatory agencies like USFDA, MHRA etc.

Online filling of the BPRs and records and performing jobs related to SAP, Operate equipment's reactor, Sparkler Filter, Candle Filters , Centrifuge, Dryers as per SOP

Dossier and document preparation as per CTD,ACTD and country specific guidelines, Review of dossiers, DMF and Technical documents, Answer query raised from regulatory authority, package insert, SmPC, PIL & MSDS preparation

2-6 Years of experience in Finished Product, RM, QMS, Stability and AMT, AMV

M.Pharm, B.Pharm, M.Sc; RM, Stability, In-process, FG, AMV and AMT, QMS, AQA, IPQA, Validation

B.Pharmacy, M.Sc, M Pharmacy ; IPQA, QMS, Validation, AQA, Stability, RM, IP, FP, Granulation, Compression, Coating, Packing

B.Pharm, M.Sc, B.Sc, Candidate should have exposure of cGMP, GLP Knowledge and understanding of regulatory requirements are essential. Experience of formulation quality control Tablets/ Topical/Capsule/ Oral solution/ Gel/ Ointment etc exposure of instruments like HPLC/ UPLC / GC/ IR/ UV/ Dissolution apparatus,KF, ICP,- MS/ ICP-OES.