Hiring for Quality Control / Quality Assurance / QC-Micro – Apply Now @ Kemwell Biopharma

 Kemwell Biopharma Pvt. Ltd is a biologics focused Contract Development and Manufacturing (CDMO) company providing services to global biopharmaceutical organisations. Kemwell’s facilities, located in Bangalore, India, are designed with technological support from a leading German biopharma company. Kemwell provides customers with cost-effective access to state-of-the-art technology for all mammalian cell culture based products’ development and cGMP manufacturing of both drug substance and drug product. Kemwell is capable of supporting novel, bio-better and biosimilar programs’ preclinical development, clinical development, cGMP clinical manufacturing and cGMP commercial manufacturing.

 

“We are Hiring”
Kemwell Biopharma Pvt. Ltd. Is hiring for below functions
1. QC- Bioassay : Executive

  • Candidates preferably with experience of 3-5 years in handling of cell lines and primary cells including all routine tissue culture practices, cell-based assays, ELISA, reporter cell line-based assays, Immunophenotyping.

2. DS- Quality Assurance: Executive/Sr. Executive

  • Candidates preferably with experience of 3-6 years in handling mAbs DS manufacturing process and change over procedure with Review of MFR, BMR, SOPs, protocols, Reports & QMS elements

 

3. QC- Microbiology: Executive/Sr. Executive

  • Candidates preferably with experience of 5-7 years in handling Media preparation, GPT and non-routine protocol based studies/validation activities with required and defined level of compliance to defined procedures and cGMP requirements & to perform /review of compressed air analysis, viable and non-viable Environmental monitoring of clean rooms and trending of data.
  • Preparation of SOPs, STPs, protocols and reports related to Microbiology section

 

3. QC- Analytical: Dy. Manager

  • Candidates preferably with experience of 10-12 years in handling coordination activities with QA, Engineering, Manufacturing department, PD and other section in QC for sampling, analysis, reporting of results and related activities in timely manner &
  • To participate in the execution of qualification (URS, IQ, OQ, PQ and RQ), execution and preparation of report for equipment related to Biochemical sections.
  • To prepare method validation protocol and ensure timely execution and compilation and report preparation. To involve in troubleshooting the problems in the analysis of method validation.
  • To ensure overall GMP, GDP and GLP compliance in Biochemical section.

 

4. QC- Physico chemical

  • Candidates preferably with experience of 8-10 years in supervising all analysis, sample distribution and outsource activities under the purview of Physico-chemical laboratory, as per approved documents and EHS recommendations & to review DRS and periodic verification of all reagents/solutions in Physico chemical section.
  • Preparation and Review of SOP, Specifications and STP for Physico-chemical section. Draft protocols, execute (wherever applicable), compile results and prepare reports for general study, method transfer, method and equipment qualification & method validation activities pertaining to Physico -chemical section.

Hiring for Quality Control / Quality Assurance / QC-Micro – Apply Now @ Kemwell Biopharma AndhraShakthi - Pharmacy JobsQualification: M.Sc(Microbiology/Biotechnology/Biochemistry)
Interested can share profiles to  [email protected]

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