General information
Company / Establishment
SEQENS is an integrated global leader in pharmaceutical solutions and specialty ingredients, delivering outstanding performance, unrivalled market responsiveness and tailor-made solutions to our customers.
Our mission is to bring R&D and industrial performance to our clients' projects with our unique skill set and a broad range of technologies.
SEQENS operates 24 manufacturing plants and 10 R&D centers in Europe, North America and Asia with 3,200 employees. More than 300 scientists, engineers and experts develop tailor-made solutions for our customers and ensure that products are successfully transferred into production.
Reference
2023-1119
Position description
Job Family / Sub-family
Quality & Regulatory - Quality Assurance
Contract type
Permanent
Job title
Specialist/Sr. Specialist, Quality Assurance Testing M/F/D
Position Context:
Provide Quality Assurance (QA) support to clinical phase API Manufacturing and Testing
Main tasks :
· Provide Quality Assurance (QA) support to clinical phase API Manufacturing and Testing
· Oversight of Quality Systems and Document Control
· Work with the cross-discipline groups to improve the effectiveness of Quality Systems
· Serve as key quality SME on project teams
· Lead or support investigations to close Quality Events, Deviations, Document in Impact Investigation, Root Cause Analysis, and CAPAs
· Review and approve cGMP Documentation: SOPs, Production batch records, testing records, logs, labels, protocols, and reports, to ensure compliance for cGMP activities
· Train production and laboratory personnel on cGMP compliances
· Review and approve activities for cGMP facility and equipment qualification and validation
· Conduct internal quality audits, track progress, and trend results
· Coordinate and facilitate quality auditing and inspection from customers and authorities
Other activities as directed by site leadership
Required skills :
Minimum BS in a scientific discipline or equivalent with a minimum of 5-7 years' experience in an cGMP regulated industry.
· Bachelor’s or Masters degree in chemistry highly preferred
· Must have experience working in a cGMP environment in the API pharmaceutical industry and have strong knowledge and thorough understanding of cGMP regulations and guidelinees
· Small molecule API experience highly preferred
· Experiences with analytical instrumentations a plus
· Experience with Quality Management Systems
· Effective written and verbal communication skills
· Self-motivated with “can do” mentality
Superior attention to detail, strong organizational skills and the ability to
Position location
Job location
USA, Massachusetts, Devens