Investigation and Compliance Quality Control Specialist

Groupe PARIMA is a Contract Development and Manufacturing Organization (CDMO), established in 1994. For over 25 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/

Investigation and Compliance Quality Control Specialist

The Investigation and Compliance Specialist will manage investigations related to quality control. He will also track and report compliance documents in the company’s quality management system.

Responsibilities:

• Initiation, drafting and conduct of laboratory investigations and trend monitoring
• Initiation and monitoring of change control (CC)
• Initiation and monitoring of corrective and preventive actions (CAPA)
• Initiation and Investigation of Quality Deviation (DEV)
• Initiation and follow-up of periodic verifications of laboratory quality documents (Analytical methods, procedures, Log books)
• Preparation of documents relating to quality management meetings
• Drafting and revision of Standard Operating Procedures (SOP)

Skills and experience required:

• Bachelor of Science (Chemistry, Biochemistry), or related discipline, from a university
• Canadian or a diploma recognized by a Canadian university or a Canadian accrediting organization as being of equivalent level in a scientific field.
• Minimum of five (5) years of laboratory experience in the pharmaceutical industry
• Good knowledge of various analytical techniques (Viscosity, PSD, HPLC, GC, UV, Karl Fisher, dissolution, specific gravity)
• Proficiency with EMPOWER software is an asset
• Good knowledge of Good Manufacturing Practices (GMP) Canadian (Health Canada) and American (FDA).
• Good technical writing
• Works well in a team and good communication skills
• Bilingual (French and English)

What we offer:

• Flexible work schedule and telework (if applicable)
• 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

* The use of the masculine gender is intended to lighten the text and make it easier to read.

Location : 4450 Cousens St., Montreal, QC, Canada, H4S 1X6