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Opportunity in R&D and Manufacturing in mAbs & Microbial Projects- Total Positions- M.Tech, M.Sc., B.Tech / B.E. in Biotechnology- 25 to 35 Positions

Hiring: R&D and Manufacturing Opportunities in mAbs & Microbial Projects A range of opportunities is available in Research & Development (R&D), Manufacturing, and Quality Control/Assurance for candidates with experience in biologicals. R&D – 15–20 Openings Positions/functions include: USP DSP Analytical Formulations Executive to Assistant Manager-level roles Manufacturing & QCA – 10–15 Openings Opportunities include: USP / QMS Specialist – Assistant Manager to Manager Process Handling – Executive to Senior Executive Quality Control Analytical – Executive to Senior Executive RM, PM, Stability and QMS functions Qualification M.Tech M.Sc. B.Tech / B.E. in Biotechnology Experience: Relevant experience in biologicals is required. How to Apply Interested candidates can share their CV at: 📧 harikrishnau@shilpabio.com Click Here For Details
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Required Executive/Sr. Executive for R and D Biotechnology QA - M.Sc/M.Pharm in Biotechnology or Biochemistry

Required Executive/Sr. Executive for R and D Biotechnology QA . 
Details are provided below 
1. Grade: Executive/Sr. Executive
2. Function: R&D Biotechnology - QA
3. Experience: 2-6 years
4. Qualification: M.Sc/M.Pharm in Biotechnology or Biochemistry
5. Job Location: Vadodara
6. Job Description:
a. Responsible for lifecycle management of development products with respect to knowledge management and lifecycle management as per ICH. Management of process changes in early phase development
b. Review of clone development and cell banking documentation and ensuring regulatory compliance in plans and reports
c. Review of product development documents such as process development reports, process descriptions, process control strategy documents etc.
d. Review of analytical developments such as method
development reports, method qualification/validation protocols and reports and ensure compliance as per latest quality and regulatory requirements
e. Development, Implementation and continual improvement of Quality Management System at R&D through SOPs, Manuals, training and audits and ensuring alignment with corporate QA and site QA.
f. Verification of Laboratory data and its integrity, ensuring good documentation practices and data reporting as per ALCOA++
g. Compilation and review of process and analytical documents for regulatory filing and CMC review
h. Control of documents, issuance of working copies, verification of raw data and archival of soft and hard copy documents based on ALCOA+ principles.
i. Knowledge on regulatory requirements on Biosimilar and biologics product specially USFDA, 
EMEA, Japan and India etc. 
7. Key responsibility:   
-To ensure "Dossier writing, Audit readiness at all times" and defending QMS and ability to respond to Audit queries from Regulatory agencies, Clients and business partners.
8. How to Apply: 
Please share your resume at:
Rosemary.varghese@sunpharma .com

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