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- PRIME RESPONSIBILITY

To co-ordinate, delegate and monitor various activities of Quality Control including microbiology

Section / Department and maintain working as per GMP and GLP norms.

- JOB. RESPONSIBILITY :

- To ensure that all the pharmaceutical products manufactured by the Company meets the quality standards and requirements of the GMP, GLP and FDA regulations.
- To ensure that all raw materials, intermediates, packaging components and formulated products are analyzed as per specifications and Standard Testing Procedures (Pharmacopoeial or In-house).
- To ensure that all the relevant documents and records for operation and analysis are maintained properly.
- To ensure successful audit, inspections and visits by parties and drug authorities of the Company’s QC including Microbiology department activities.
- To ensure that all instruments in Quality Control and Microbiology department are qualified, calibrated and equipment validated as per schedule, both in-house and outside agency records maintained.
- Ensure IQ, OQ, DQ, PQ of instruments in QC Lab and approval of reports for the same.
- As and when requirement for new instrument is realized to make the management aware of it and arrange the justifications and quotations for its procurement.
- To get the product analyzed and tested within time as per the sampling procedures giving approval of its release.
- To ensure stock of working standards, reference standards and microbial cultures by regular procurement and storage of the required items. To arrange and maintain at optimum quantity, all chemicals and glassware for QC and Microbiology Laboratory.
- To check, approve and reject Raw Material / Packaging Material /Bulk/ Finished Products / Stability samples and in process sample and reports. In absence, designee will be responsible to check and approve or reject Raw Material / Packaging Material / Bulk/ Finished Products/ Stability samples and Inprocess sample reports.
- To ensure maintenance of control samples of API with logs.
- To monitor, maintain and approve stability samples for stability study of finished products.
- To review approve stability protocols and results.
- To ensure that all the necessary testing is carried out and the associated records are evaluated.
- To improve the administration and productivity of QC laboratory including Microbiology section.
- To check and approve SOPs, STPs, GTPs and Specifications, sampling instruction,



test methods and other procedure related to Quality Control and Microbiology section for finalization by QA.
- To investigate justify and approve OOS, OOT and deviation in QC Lab.
- To impart scheduled training to QC Chemists as per regular training as well as imparting current information.
- To monitor and co-ordinate all In process QC activities, reporting results in minimum time so as not to affect production cycle time.
- To review and approve analytical test reports and COAs.
- To review and sign Batch Manufacturing Record for batch release.
- To review and approve artworks – labels, cartons, leaflets for regular products.
- To review and verify logbooks, notebooks and raw data.
- To be part of Validation team and Internal audit team to keep the working in departments as per GMP.
- To participate in external audits for vendor approval.
- To review and approve reports related to process validation and its documentation.
- To approve method validation protocol, approve and maintain documents for the same.
- To perform periodic trend analysis for OOS, Deviation etc.
- Ensure that safety protocols are followed in QC.
- To ensure compliance with data integrity procedure in both electronic and manual system.
- To plan analysis of samples of Raw Material and Packing Material from new vendors in coordination with F&D.;
- To assist in planning of F&D; sample analysis as instruments of QC shall be required.
- To supervise day to day QC Lab activities.
- To approve and monitor any Contract analyst.
- Approval and monitoring of Suppliers of materials and contract manufacturers.
- To look into suggestions for improvements in working conditions for Quality Control Department and to take appropriate action.
- To exercise control over expense by means of :
- Reducing idle time of staff.
- Regulating leave schedules and reducing absenteeism.
- Establishing rapport with all staff by prompt action in resolving grievances, disputes and to maintain proper discipline with the help of HRD department where necessary.
- To communicate downward relevant information to all concerned for effective implementation of Company’s policy, plan, changes, etc.




- To select/ recruit in collaboration with HRD department, personnel required.
- To maintain staff at an optimum level as to prevent any stoppage of regular activities.
- To prepare job assignments, review and appraise the employees as per company procedure.
- To prepare monthly reports and annual budgets, etc.
- Any other work as may be assigned by the Company from time to time.

Department

Quality / Project Execution

Location

Nagpur

Education/Qualification

Bachelor of Science (B.Sc. in Microbiology) and a Master of Science (M.Sc. in Microbiology)

Posted On

27-Oct-2026

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- Fabrimax Engineering Private Limited
- Fabtech Engineering Private Limited
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📌 QC Manager (Nagpur)
🏢 Ssfm Group
📍 Nagpur