QA Executive
@ 3M’s healthcare business
B. Pharm/M.Pharm/M.Sc/B.E.(Chemistry, Microbiology,
Biotechnology)
3M’s healthcare
business offers innovative products and solutions for skin & wound care,
infection prevention, oral care, health information systems, drug delivery and
food safety. Our goal is to provide
trusted products that promote health and improve the quality, cost and outcomes
of patient care. We do this by leveraging 3M technology, world-class
manufacturing capability and a presence in over 200 markets around the globe.
The person hired for the position of Quality Control Engineer will lead the
effort to support business through implementation of strong Quality Assurance
Systems at Ranjangaon HCBG lab as well as ensure compliance to 3M &
Regulatory/Statutory requirements. This position would be based at 3M
Healthcare Manufacturing plant at Ranjangaon, Pune.
• Preparation
of Validation Master Plan.
• Execution
and Review of Process validation Protocols/summary reports and Product quality
review
• Execution and review of Change control
procedures.
• Handling of
event, deviation, OOS and OOT.
• Providing
on-job, instrument training, Calibration, SOP, GMP training and documentation
training for reportees
• Prepare
Risk Assessment as per SOP requirement for newly installed instrument,
processes, Approach.
• Review DQ,
IQ, OQ and PQ documents.
• Assist QA
for customer complaint investigation, root cause analysis and CAPA
• Handling
Change control, Laboratory Deviation and Document Management.
• Supporting
WHO GMP implementation at site and provide training to the other staff members.
• Planning
and execution of Processes validation, cleaning validation activity and method
transfer activity.
• Coordinate
with other functions to ensure issue resolutions related to GMP/Product/any
process • Lead 5S, Kaizens, Yeild Improvement & process improvment projects
in lab
• B. Pharm/M.Pharm/ M.Sc/B.E. with 2-5
years of experience of working in Medical Device/Pharmaceutical Industry/ Food
Industry/Engr.
• B. Pharm/M.Pharm/M.Sc/B.E.(Chemistry,
Microbiology, Biotechnology) with minimum 2-5 years of experience of working in
Medical Device/Pharmaceutical Industry/ Food Industry/Engeneering industry.
• Has a strong background of Quality
Assurance & Process improvement capability
• Must have experience in handling team
of associates
• Ability to effectively communicate up,
down and across the organization
• Effective written and verbal
communication skills
• Have faced audits from FDA, ISO &
WHO-GMP, CE
• Location: Ranjangaon, Pune
TO APPLY CLICK HERE
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