Associate Scientist – DQA (R&D QA) - Biotech
About the Job
Associate Scientist – DQA (R&D QA) - Biotech (Must)
Education – Master's (M.Pharm) in Biotechnology
Experience – 05 to 10 Years (Biotech experience mandatory)
Key Responsibilities –
1. Review Biotech R&D documents as per ALCOA++ requirements, metadata review, and data integrity checks.
2. Review of Process Development Reports, Tech Transfer documents, Process Characterisation Reports. Coordinate DOA support for Tech Transfer activities. Review Clone Development, Clone Characterisation, and Packaging Documents.
3. Provide QAMS review support for evaluation and approval of Quality Management notifications (Deviation, Change Control, CAPA, LIR).
4. Manage QAMS: Tracking notifications, coordinating with R&D, periodic review and trending as per SOP, and troubleshooting the QAMS system.
5. Coordinate with CQA and HO-IT for implementation of Corporate SOPs at Biotech R&D and manage QAMS for Corporate Change Controls.
6. Conduct Internal Audits for R&D compliance checks.
7. Support the implementation of new systems at R&D as part of system improvement.
8. Support archival, issuance, and destruction of R&D documents.
About the Company
Overview
BIG PHARMA JOBS is India’s leading recruitment platform dedicated exclusively to the Pharmaceutical industry. Since 2010, we have been connecting top talent with leading pharma companies through our specialized recruitment services.
We operate under our parent company, BIG IDEAS HR Consulting Pvt. Ltd., a trusted name in the HR industry. Headquartered in Ahmedabad, we have expanded our footprint with branch offices in Pune, Bangalore, Indore, Noida, and more.
Over the past decade, we have proudly partnered with 1,000+ pharma companies and successfully placed over 25,000 candidates across various domains and levels.
To further strengthen our commitment to the pharma ecosystem, we have recently launched our own job portal – a dedicated platform designed to serve pharmaceutical professionals and companies alike. This portal aims to be a one-stop recruitment solution, simplifying the hiring process and job search experience in the pharma sector.
At BIG PHARMA JOBS, our vision is to create India’s most trusted and comprehensive job portal for the pharmaceutical industry – empowering careers and building organizations, one placement at a time.
Skills
Key Details
- Experience:
- 05 to 10 Years
- Job Domain/Function:
- Biotech, R&D, Quality
- Job Type:
- Work From Office
- Employment Type:
- Full Time
- Number of position(s):
- 1
- Educational qualifications:
- M.Pharma