Groupe PARIMA is a Contract Development and Manufacturing Organization (CDMO), established in 1994. For over 30 years, we have developed an expertise in the development and manufacturing of non-sterile liquids, suspensions and semi-solid drug products. https://www.groupeparima.com/fr/
QA Specialist – Validation and PDS Support
This position supports quality assurance activities related to:
- Review and approval of validation documents (process, cleaning, equipment)
- Qualification and management of suppliers
- New product introduction activities as part of the Product Development Services (PDS) program
- Review of controlled documents in a GMP-compliant environment
Responsibilities:
Validation and Qualification:
- Review and approve process and cleaning validation protocols and reports
- Review equipment and utility qualifications
- Participate in validation meetings, as needed
- Participate in the drafting/review of deviation (investigation) reports related to process, cleaning, and equipment validation
- Review/approve change controls related to process, cleaning, and equipment validation
- Implement and follow up on related CAPAs
Supplier Qualification Program:
- Review supplier questionnaires, evaluations, and audits (paper or on-site)
- Collaborate with technical and purchasing departments to ensure qualification according to cGMP requirements
- Maintain the approved supplier database
- Draft deviation (investigation) reports related to qualified suppliers
- Review/approve change controls related to the supplier qualification program
- Implement and follow up on related CAPAs
Support for Product Development Services (PDS):
- Participate in cross-functional meetings for new product introductions
- Review and approve change controls, master records, master documents, etc.
- Ensure documentation compliance for client projects
Documentation and GMP Compliance:
- Review and approve controlled documents (SOPs, work instructions, specifications)
- Work within the ACE system (PSC Biotech) for all activities related to document lifecycle management
Other Responsibilities:
- Participate in the continuous improvement of quality processes
- Assist with the preparation or conduct of client or regulatory audits, as needed
Skills and experience required:
- Bachelor’s degree in Chemistry, Biochemistry, Microbiology, Pharmaceutical Sciences, or a related discipline
- Minimum of 5 years’ experience in Quality Assurance within the pharmaceutical, biotechnology, or CDMO industry
- Demonstrated experience in process/cleaning validation and equipment qualification
- Experience in supplier management and GMP documentation
- Solid knowledge of Canadian (Health Canada) and US (FDA) GMP regulations, and ICH Q7, Q8, Q9, and Q10 guidelines
- Ability to work in a dynamic, client-oriented environment
- Attention to detail, autonomy, organizational skills, and critical thinking
- Excellent writing and communication skills
- Bilingualism (French and English) is required
What we offer:
- Flexible work schedule and telework
- Medical – dental & travel benefits
- Group retirement plan
- Recognition program & social activities
- Personal days
- Employee assistance program & online medical service
- Hot Beverages (Hot chocolate, Coffee, Mokaccino)
- Accessible by public transit or free parking
- Referral program
- Subsidized meal program