Assistant Manager - QA

Role & responsibilities

Ensure all the QA activities are followed like, issuance of

BMR/Work sheets/ necessary formats/ log books are in place

and guidance for all activities of QA Executives

• In absence of QAM release of FG/RM/PM etc.
• Review of BMR/QC work sheet which are checked by QAexecutives.
• Ensure complaints are properly noted and documented.
• Documentation of product recall and ensuring return of goods
• Preparation of Annual Product Quality Review
• Responsible for coordination in preparation and review of SOPs
• To coordinate for internal audits, follow up on actions to be taken up to the CAPA
  compliance.
• Review of Stability study data and Monitoring Program.
• Compilation of daily deviation reports and develop corrective actions.
• Documentation of change control documents.
• To assist for of statutory inspections, customer audit, regulatory Audit and its compliances
• Verification of training schedules are properly followed documented properly.
• Controlling all QA & QC documents
• Preparation of Master formula records (MFR)
• Delegation of QAM authorities like batch release, approval of CAPA, and wherever required in consultation with QAM in the absence of QAM. Coordinate calibration activities in the factory and where required appoint outside agencies
• Assist QAM for various validation activities like qualification, documents like protocol, report.
• Documentation and Review of all RM/PM vendor evaluation and assessment.
• Coordinate with concern department to prepare and implement the CAPA.
• Housekeeping: To maintain the facility clean. To avoid and to control the contamination. To
  maintain the GMP Monitor daily basis documentation.
• Review and assessment of the daily work form executives.
• Review and verify the Quality management system documents like Change control, Deviation,
  OOS etc.
• In absence of QAM do the necessary work. Handling of other Safety department activities

• Handling of Computer Software applications

• Customer Questionnaire filling and documented.

Preferred candidate profile

M.Sc.

Experience in QA dept

Perks and benefits

Negotiable