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வெற்றி என்பது உன்னை உலகத்திற்கு அறிமுகம் செய்வது.... தோல்வி என்பது உன்னை உனக்கே அறிமுகம் செய்வது !!!

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Monday, March 14, 2011

post graduation in Biotechnology/ biochemistry/ Microbiology/Chemistry: QA-Manager(Biologics)





For Internal Use of Employer (Please don't delete or modify while replying to this email)
Monster Resume ID: 13917159      Personal Folder ID: 9433392

Dear ,

Position - Manager – Quality Assurance - Biologics

Exeperience – 6 - 8 Years

Qualification – Post graduation in Biotechnology/ biochemistry/
Microbiology/Chemistry.


Job Description :
•Should have experience in managing the quality function of
commercial manufacturing unit catering to India and semi-regulated
markets.
•Should be team leader as well as team player with sound analytical,
communication and interpersonal skills.
•Should be able to review the QC reports and guide QC function for
GMP compliance.
•Should have competencies required for understanding and analyzing
the microbiology, immunology and bioassay analysis reports.
•Experience in handling Internal audits, CAPA, deviations, change
controls, OOS, OOT, investigations related to process and product
failures, market complaints etc.
•Experience in handling technology transfers and analytical method
transfers from R&D to plant.
•Should have hands on experience in conducting qualifications of
manufacturing and services equipment (DQ/IQ/OQ/PQ).
•Should have experience in validating HVAC, Purified water, WFI, Pure
steam, Process gases etc.
•Should be well versed with process validations and analytical method
validations.
•Minimum One to two years experience in the managerial function of
manufacturing plant.
Desirable : Must have experience of at least five years in the QA
departments of
reputed biological industries working on recombinant therapeutic proteins .


Knowledeg of:
1. Biosimilars / guidelines - process knowledge, execution of validations

2. Analytical method qualifications / validations.

3. Biotech Process(Media prep-upstream-Downstream process), clean utilities .

4. Bioreactor validations, water system validations.

5. Manufacturing and maintenance.

Regards:
Ranjana-080-41663048
Email id-ranjana@yuchra.com





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