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
2022-765
Position description
Job Family / Sub-family
Quality & Regulatory - Quality Assurance
Contract type
Permanent
Job title
Specialist, Quality Assurance Product M/F/D
Position Context:
Ø Purpose of the position:
Ensure that practices on site follow site procedure and GMP.
Main tasks :
Mission 1: Batch record review
· Review production batch records to ensure that they comply with site procedures and GMP.
· Verify quality control tests results before releasing a batch.
· Review and assess deviations’ impact before releasing a batch.
· Perform coaching, mentoring, and oversight of deviations
· Track and coordinate deviation investigation activities to ensure timely closure
· Check finished good stock and product sealing and labelling.
· Can present the batch record review process during audits and inspections.
Mission 2: Assist product Quality Manager
· Review records to ensure that they comply with site procedures and GMP:
o Maintenance records.
o Validation results.
o Pest control results.
o Environment monitoring results.
o Stability results.
· Revise QA procedures.
· Inspect and audit areas.
· Investigate in case of complex deviation.
· Release Raw material and Packaging material for all manufacturing process
Mission 3: Project Management
· Monitor QA Batch review and release activities
Required skills :
Pharmacist degree. Must be registered for batch release responsibilities.
B.Sc. in life science.
· At least 2 years’ experience in QA/QC functions, cGMP and ISO 9000.
· Experiences in pharmaceutical and/or chemical industries.
· Background in quality control / assurance
· Rigorousness
· Attention to detail
· Organized
· Great communication skills
Position location
Job location
USA, Massachusetts, Newburyport
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