To review, approve and authorize specifications, sampling instructions, test methods, analytical work records and other QC procedures.
Review of work allocation of all subordinates based on production planning & priorities.
Ensure that Good laboratory Practices (GLP) is followed in Quality Control Department
To ensure timely sending of samples of Raw Materials and Finished products to contract testing laboratory and their follow-ups.
To carry out investigation of OOS test results
To attend market complaints related to product quality.
To ensure effective implementation of current pharmacopeia and its amendments
To perform self inspection of Quality Control Department, Production area, Raw Material store and Finished Goods stores with self inspection team.
Operation of LIMS sample Manager
To attend FDA audits and its compliance related to QC department.
To update Quality Control department manual.
To prepare monthly activity reports of QC department.
To prepare annual budget for capital goods required for Quality Control Department.
Recruitment of Quality Control staff as and when required.
Ensure that Good laboratory Practices (GLP) is followed in R&D laboratory
Required Candidate profile
Should be experienced in working in a Solid Oral Dosage form testing. Should have adequate knowledge in understanding cGMP requirements as per US/EU guidance. Well versed with ICH/WHO/PICS guidance and requirements.
Expected to have knowledge of sophisticated instruments like AAS, ICPOES/ICPMS, GC-HS and HPLC/UPLC. Experience on Chromeleon 7.2 Chromatographic Data System is expected.
Salary: INR 13,00,000 - 18,00,000 PA.
Industry: Pharma / Biotech / Clinical Research
Employment Type: Full Time, Permanent