Quality Assurance Officer

Job Description

Position: QA

Department: Quality Assurance

Qualification: MSc, M. Pharm, B. Pharm.

Experience (In years): 4 - 5 Years

Any Preference: Medical device/Injectable experience

Responsibilities:

Execution and compliance to Quality Management System (QMS) as per ISO 13485, MDR 2017 & GMP norms.
Assertive communicator, able to work cross-functionally, perform IPQA activity.
Interpret and implement quality assurance standards and procedures.
Responsible for preparation of SOP, Protocol , MFR, BMR, BPR, MDF etc.
Review and control of SOPs, BMR/BPR, logs, and GMP documentation.
Support batch review and release activities.
Quality risk management, FMEA, incident management.
Coordination with QC, Production, Engineering, Warehouse, Regulatory, Purchase, R&D, Pharmacovigilance, and other functions.
Participate in internal audits, external audits, and regulatory inspections.
Document internal/ external/ vendor audits and compliance.
Capable of training operators on GDP, GMP, GLP, hygiene, gowning, and change control etc.
Prepare reports to communicate outcomes of quality activities.
Responsible for Validation/Qualification/process activity.
Support complaint handling, investigations, and risk assessments.
Responsible for QMS (Change Control, Deviation, Investigation etc.) & handling of OOS, Excursion Compliance, CAPA, Incident.