Job Title

Experience - 16 – 20 yrs Location - Pithampur Qualification- M.Sc./ M. Pharma / B. Sc. / B Pharma RESPONSIBILITIES Daily planning of analytical activities, resource management and work allocation. Plan and execute sampling and analysis for raw materials, packaging materials, intermediates & finished products. Review and /or Approval & Implementation of Standard operating procedure Review and /or Approval of Implementation analytical protocol and analytical reports Review and /or Approval of Qualification and calibration of Instruments. Investigating and review of Investigation related to Laboratory Events, OOS, OOT and Deviations. To ensure the QC related electronic data management compliance such as computer system validation, electronic data backup, storage and retrieval. Conduct induction training, on-the–job, annual training and analyst qualification to enhance analytical skills of quality control personnel. Procurement and inventory control of material and equipment required for QC activities. Review analytical activities related to process validation, cleaning validation and analytical method validation. Authorise to release of raw material, intermediate, stability samples and working standards in absence of QC Head through LIMS. Monitoring of non-routine Activities like stability study, working standard Management, calibration Management, Analytical Method Transfer / method Verification. Responsible person for all QC activities in absence of Head – QC. DESIRED SKILLS Should have adequate experience of facing various regulatory Inspections like USFDA, MHRA, EMA, TGA etc. Adequate experience of auditing finished dose formulation units, API and Intermediate/KSM vendors. Experience of working in API unit would be preferred. Very good functional knowledge and application. Proactive approach to internal and external queries. Managing multiple stakeholders. Should hold high standards of business ethics. Excellent communication skills and decision-making skills.