Title:  Manager QC (Head Micro Section)

-:Position details:-

Position:          Manager/Sr Manager( Head - Micro)

Grade:               (G-10)

No. of Position: 1 No.

Job Location: Dewas Formulation

Qualification: M.Sc.- Micro/Biotech / B.Pharma/M.Pharma

Experience: 18-25 years of experience in Micro Section

Candidate from Regulatory Plant will be preferred

Job Description:-

• Ensure compliance to cGMP and safety standards in the Microbiology Lab.
• Conduct work planning and allotment to analysts for sample testing.
• Ensure Calibration/Preventive Maintenance/Qualification of laboratory equipment and instruments
• Ensure environmental monitoring of Microbiology Laboratory.
• Ensure sample management & sanitization activity of Microbiology lab sample
• Ensure microbiological analysis of sterile and non-sterile raw materials, in-process samples and finished products, PM and Stability.
• Evaluate and ensure analytical data and calculation of results.
• Assist with reporting and verification of test results/reports.
• Ensure integrity, accuracy and adequacy of the analysis performed.
• Ensure timely preparation of Validation protocols/reports other quality documents.
• Initiate /execute QMS activity pertaining to micro lab activity.
• Ensure review & approve QMS activity pertaining to micro lab activity.
• Provide microbiological support in plant validation & qualification activities.
• Provide troubleshooting support to analysts.
• Ensure for the in process activities related to Sterility Assurance on shop floor.
• Ensure timely training and qualification of all Microbiology personnel as per schedule/requirement.
• Coordinate for various activities with laboratories & manufacturing/customer’s and ensures to provide timely & necessary support to fulfil organizational requirements. 
• Support IPQA, QA, Production, PDL, Regulatory, Stability Lab, API and Validation for microbiological requirements.
• Co-ordination for internal/external audits, and ensure compliance during internal as well as regulatory audits.
• Ensure conformance to internal Quality Systems requirements and relevant markets’ regulatory guidelines on cGMP with respect to Microbiological requirement.
• Ensure for technical up gradation of activities whenever required.
• Actively participate in all Validation, Qualification and process enhancement activities and to ensure conformance to internal Quality Systems requirements and relevant markets’ regulatory guidelines on cGMP with respect to Microbiological requirement.
• Ensure training on revised SOPs/GPs/Protocols and other quality documents to analysts in Microbiology Laboratory.
• Ensure Identification & assessment of Microorganisms.
• Ensure Disinfectant Efficacy Test (DET).
• Ensure Container Closure Integrity Test (CCIT).
• Biological indicator inoculation, incubation and observation.
• Ensure for Media Management and GLP activities with respect to Microbiological requirement.
• Ensure and Review of Change controls, SOP’s, STP’s, GP’s & Validation protocols/reports and other quality documents for accuracy and completeness with respect to Microbiological requirements.
• Ensure timely revision & implementation of various effective documents i.e. GSOPs/SOPs/GPs/Protocols etc.
• Ensure timely prepare Monthly trends, Quarterly summary and annual summary reports of water samples.
• Ensure timely Conduct microbiological & chemical testing of the water systems.
• Ensure timely performed BET of water samples, preparation of chemical reagents and sampling activities of water system.
• Ensure Analytical Method validation with respect to Microbiological requirement.
• To ensure contamination controls implemented and followed at site as per Contamination Control Strategy (CCS) and respective procedures