Manager Quality control

Experience -

Location -

Qualification-

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.