Quality Assurance Specialist - Validation and Product Development Support

Groupe PARIMA Inc; Montreal; On-site; CAD 70,000 - 90,000; Full time

Job summary

A leading CDMO company in Montreal is seeking a QA Specialist to manage quality assurance activities. Responsibilities include reviewing validation documents and ensuring compliance with GMP regulations. The ideal candidate has a Bachelor's degree and at least 5 years of experience in Quality Assurance within the pharmaceutical industry, demonstrating strong bilingual abilities in French and English.

Benefits

Flexible work schedule and telework

Recognition program & social activities

Employee assistance program & online medical service

Free parking available

Qualifications

• Minimum of 5 years’ experience in Quality Assurance within the pharmaceutical, biotechnology, or CDMO industry.
• Solid knowledge of Canadian and US GMP regulations.
• Excellent writing and communication skills.

Responsibilities

• Review and approve validation documents in a GMP-compliant environment.
• Participate in validation meetings and draft deviation reports.
• Assist with client or regulatory audits as needed.

Skills

Process / cleaning validation

Supplier management

GMP documentation

Attention to detail

Bilingualism (French and English)

Education

Bachelor’s degree in Chemistry, Biochemistry, Microbiology, or Pharmaceutical Sciences

Job description

Groupe PARIMA is aContract 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

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.

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

Recognition program & social activities

Personal days

Employee assistance program & online medical service

Accessible by public transit or free parking

Referral program

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