Senior Executive - Quality Control (Pithampur)

Be the First to Apply Division Piramal Pharma Solutions Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide. For more details, please visit : Job Title Senior Executive
- Quality Control QC Microbiology: Executive Experience: 2-4 years Qualification: M.Sc. (Microbiology/Biotechnology) Relevant Experience: Candidate should have good exposure of Microbiology Testing (Microbial Limit Test, Sterility, BET, PET etc.) Environmental Monitoring and Water Monitoring. Candidate should have sound knowledge of various equipment's like Autoclave, Vitek, Toxinometer, TOC etc. Candidate with exposure of LIMS will be preferred. Key Roles/Responsibilities:
- Ensure Microbiological Setting monitoring of manufacturing area, microbiology laboratory as per procedure.
- Maintenance and calibration of all instruments and equipment’s in Microbiology Section.
- To test, check & maintain appropriate documentation in accordance with the cGMP & GLP guidelines of Raw Materials, Packaging Materials, Finished Goods, In-process Samples and Stability Samples from Microbiological point of view.
- Test, check & maintain appropriate documentation of raw material, packaging material, finished product of Sterility testing.
- Maintenance and calibration of all instruments and equipment’s in Microbiology Section.
- Facing internal audits & external audits and ensure compliance.
- Carry out OOS investigation along with HOD.
- Control of operating expenses.
- Other work related to microbiology as per requirement.
- Ensure effective implementation of system and procedures.
- Ensure data entry and approval in system.
- Training of new persons as per Procedure.
- Ensure effective implementation of systems and procedures as per GMP, GLP, ISO 9001. ISO 14001 and other regulatory requirements.
- Monitor and implementation of all pharmacopeia changes as per IP/BP/USP/EP/JP
- To monitor and maintain the incubators in Microbiology laboratory.
- To ensure timely sampling and analysis of various types of water.
- Support to site DICO (Data Integrity Compliance Officer) for monitoring and implementation of actions related to Data Integrity awareness at site. Apply on Kit Job: kitjob.in/job/4mtt1i