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Quality Control, Pharma Industry, R and D, CSIR, Food Industry, Pathology, Medical Writing, coding

Required Freshers or Experienced ProductionExecutive - Upstream /Downstream for Probiotic Pharmaceutical Manufacturing Company

Unique Biotech is looking for candidates who have: 0-2 years of experience in upstream or downstream production operations Join their team and contribute to the production of innovative probiotic healthcare solutions while advancing your professional career. Required Freshers or Experienced Production Executive - Upstream /Downstream Join  Unique Biotech's growing team and be a part of an innovative Probiotic Pharmaceutical Manufacturing Company committed to delivering high-quality healthcare solutions. Details are provided below  1. Position: Production Executive Upstream / Downstream 2. Experience: 0-2 Years 3. Industry: Probiotic /Pharmaceutical Manufacturing 4. Location: Shamirpet, Hyderabad 5. How to Apply:  Apply by sending your resume to: priyadarshini@uniquebiotech.com Contact: 9966041417 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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