ProPharma Group, a national company serving the qualification, compliance and technical service needs of clients in the pharmaceutical, biotechnology and medical device industries. Our validation professionals include chemical, electrical, mechanical and computer engineers, chemists, microbiologists and other specialists. ProPharma Group provides an excellent work environment and a culture of experience, integrity, and commitment. Full-time, consulting and contract opportunities available.
Responsibilities:
Working knowledge of Quality Systems, GMPs, SOPs, batch review/disposition, review/approval of investigations, review/approval of CAPA, and review/approval of change control.
Strong technical writing skills associated to SOP development, CAPA, change control, and investigations.
Strong working knowledge of cGMP regulations, USP standards, and ICH and FDA guidance documents.
Extensive travel required.
Qualifications:
5+ years experience in Quality Assurance type role within Pharmaceutical, Biotechnology or Medical Device industries.
B.S. /B.A in Scientific discipline (Engineering, Chemistry, Biology, Microbiology or related life science)
ProPharma Group - 11 months ago
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