About Company:
Shilpa Biologicals is a biotech company focused on innovating and developing high-quality affordable biopharmaceuticals for patients worldwide, through cutting-edge research and creative collaborations
Vacancy Details:
Job description:
Job Vacancy at Shilpa Biologicals, Hubli – Dharwad, Karnataka.
Department: Quality Assurance – QMS
Designation: Senior Executive – Assistant Manager
Experience: 4 – 8 Years
Qualifications: B. Pharma / M. Pharma / M.Sc. / B. Tech / M. Tech
No of Position: 1 No
Budget: 3 – 9 Lac
Key Responsibilities:
- Quality Management System (QMS) Oversight: Review, track, and manage QMS documents, ensuring timely completion, updates, and closure while maintaining compliance with GMP/GDP standards.
- Standard Operating Procedures (SOPs): Prepare, review, and approve SOPs, protocols, and reports, as well as manage change controls and related documentation throughout manufacturing and packaging processes.
- Deviation and Investigation Management: Review deviations and investigations, track corrective actions (CAPA), and manage documentation related to market complaints, including trend analysis and root cause identification.
- Audit Support: Prepare for and assist in internal, external, and vendor audits, including documentation management, audit report preparation, and addressing observations or non-conformances.
- Quality Risk Management: Support quality risk management activities, participate in investigations with relevant departments and Subject Matter Experts (SMEs), and contribute to process improvements by identifying opportunities for new procedures or initiatives.
- Monitoring and Reporting: Monitor GMP/GDP compliance across the facility, prepare QMS trend reports by analyzing quality metric data, and escalate any non-compliance concerns.
Employee Benefits – Medical Insurance, Accidental Insurance, Relocation Allowances, Two Saturday’s Off, Canteen and Transportation Facility.
How to Apply?
Interested candidates are invited to send their updated resumes to hrd_bio@shilpabio.com
Join us at Shilpa Biologicals to be a part of a dynamic environment committed to innovation and excellence in the pharmaceutical sector!