QC

Candidates should have experience in Formulations regulated manufacturing company such as USFDA & MURA, EU with audit exposure.

Method Development, Method Validation, Method Verification of DS, DP as per In -House and monograph methods. Testing of analytical samples by using HPLC, GC, Dissolution, AAS, Titrations, Wet analysis.

Strong understanding of OSD manufacturing processes and knowledge of cGMP and relevant regulatory requirements. Candidate should have good exposure to QC instruments HPLC/ GC/ LCMS, Dissolution, UV Spectrophotometer/ KF/ Autotitrator / Malvern analysis and trouble shooting 

To ensure timely completion of analysis and data completion for the same. To be responsible for all activities in the Quality Control Laboratory, including cGLP, documentation and implementation of departmental quality systems. M.Sc / BPharm or any relevant degree

Exposure to OSD Manufacturing operations like Granulation, Compression, Pellet coating, Capsule filling, Primary Packing and Secondary Packing. Expertise in e-BPR and e-log will be added advantage. Experience in analysis of Solid Oral - FP, In-process or Stability samples. Experience of HPLC, UV spectrophotometer and Dissolution Tester operation. Experience of Analytical Method Validation/Transfer Solid Oral. Experience of GC, ICPMS and/or LCMS operation.

Gufic Biosciences Ltd is a leading pharmaceutical industry since 1970 and is one of the world’s largest Lyophilization injectables & wide range of API products, at Navsari (Gujarat). International accreditation of WHO, GMP, EU, Canada, Russia, Anvisa, etc.

Collaborate with outsource parties to full fill laboratory requirement in timely manner. Previous experience in analytical method validation would be an added advantage.

Good exposure require in IPQA - Sterile, Qualification Sterile & OSD & Documentation Cell. Finished, AMV & Stability Section, knowledge of Instrument - HPLC. GC. Preferably know-how of Chromeleon Software.

B. Pharma. /B.Sc. Biotech./B.Sc. Medicinal Chemistry/B.Sc. Pharmaceutical Chemistry M.Pharma/M.Sc. Biotech /M.Sc. Medicinal Chemistry /M.Sc. Pharmaceutical Chemistry. To assist in preparation of purchase orders and send copies to suppliers and to departments originating requests. Follow up with suppliers in respect of timely supplies of products with respect to the issued purchase orders.