Quality Assurance Officer/Executive

Job Description:

Position: QA Asst Manager ( OSD , ORAL LIQUID & OINTMENT FACILITY) Position: QA Asst. Manager Vacancy: 01 Location: VAPI- GUJARAT Experience: 10 to 15 Years Qualification: B. Pharma / M. Pharma Core Technical Expertise:  IPQA (In-Process Quality Assurance): Hands-on experience in monitoring manufacturing and packaging processes, line clearance, and in-process checks.  Documentation & QMS: Proficiency in DOC-QMS systems, SOP preparation, deviation handling, and change control.  Technology Transfer (TT): Involvement in TT activities including protocol review, execution, and coordination between R&D and manufacturing.  21 CFR Part 11 Compliance: Familiarity with validated software systems that meet FDA electronic records and signatures requirements.  Validation & Qualification: Strong understanding of equipment qualification (DQ, IQ, OQ, PQ), process validation, and cleaning validation.  Automation & Digital Systems: Exposure to automated quality systems and digital platforms for manufacturing documentation.  E-BMR & E-Log: Experience with electronic Batch Manufacturing Records and Logbooks for real-time documentation and traceability.  Quality Management Systems (QMS): Implementation and maintenance of QMS aligned with regulatory standards .  Risk Assessment: Ability to conduct and document risk assessments for processes, equipment, and product quality.  Strong communication and leadership skills.  Familiarity with regulatory audits and CAPA management. Leadership & Audits:  Team management and cross-functional coordination  Conducting internal audits and vendor audits with corrective action planning