What are the responsibilities and job description for the QA Specialist - Pharma #W2 role position at TekOne IT Services Pvt. Ltd.?
Job Title: QA Specialist
Shifts: 7am-7pm or 7pm-7am (12-hour shifts)
Position Summary
The QA Specialist provides Quality Assurance support for GMP manufacturing, overseeing master/working cell banks, biological bulk drug substances, and finished products for human consumption. Responsibilities include on-the-floor QA oversight, compliance monitoring, and quality improvements.
Key Responsibilities
Shifts: 7am-7pm or 7pm-7am (12-hour shifts)
Position Summary
The QA Specialist provides Quality Assurance support for GMP manufacturing, overseeing master/working cell banks, biological bulk drug substances, and finished products for human consumption. Responsibilities include on-the-floor QA oversight, compliance monitoring, and quality improvements.
Key Responsibilities
- Conduct QA oversight of GMP operations (75% of time on the floor).
- Support client projects with room release, process observation, and real-time documentation review.
- Perform Acceptable Quality Limit (AQL) visual inspections.
- Review and approve batch documents.
- Generate/revise GMP documentation and compile deviations.
- Audit manufacturing areas for adherence to procedures.
- Participate in quality and process improvement initiatives.
- Provide guidance on cGMP compliance and training.
- Education:
- Master's degree in a scientific field (0-2 years of experience)
- OR Bachelor's degree (2-4 years of experience)
- Experience: Quality Assurance/Control in biologics or regulated industries.
- Knowledge: Familiarity with GMPs, 21 CFR regulations, and biological manufacturing processes.
- Skills: Proficiency in Microsoft Office, LIMS, Master Control, and Trackwise preferred; strong analytical and decision-making abilities; teamwork and independent work capability.
