Quality Assurance Specialist - Validation and Product Development Support

Groupe PARIMA Inc; Montreal; Hybrid; CAD 75,000 - 90,000; Full time

Job summary

Groupe PARIMA Inc is seeking a QA Specialist to oversee quality assurance activities related to validation and Product Development Services. This role involves reviewing validation documents, managing suppliers, and ensuring compliance within a GMP environment. The ideal candidate will have a strong background in quality assurance in the pharmaceutical industry, with excellent communication skills and a detail-oriented approach. Flexible work options and various employee benefits are included.

Benefits

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

Qualifications

• 5+ years’ experience in Quality Assurance within pharmaceuticals.
• Solid knowledge of Canadian and US GMP regulations.
• Excellent writing and communication skills.

Responsibilities

• Review and approve validation documents.
• Participate in cross-functional meetings for new product introductions.
• Assist with client or regulatory audits.

Skills

Quality Assurance

Process Validation

Supplier Management

GMP Compliance

Attention to Detail

Bilingualism

Education

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

Job description

Groupe PARIMAis 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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