Duchesnay Inc. is a privately-owned pharmaceutical company specialized in the development, manufacturing and distribution of prescription Women's health products.
The company is located in Blainville, in the Lower Laurentians.
Under the direct supervision of the Director, Quality Control & Assurance, the chosen candidate will be responsible for performing the following duties:
Job Description and Responsibilities:
- Coordinate the department's activities by ensuring compliance with GMP regulations and guidelines (non-conformity, change controls, corrective and preventative actions, environmental monitoring programme, equipment, hygiene programme, quality control, etc.)
- Coordinate the department's activities by ensuring compliance with ISO 13485 (Medical devices) laws and regulations (non-conformity, change controls, corrective measures, etc.)
- Perform sampling (finished products, packaging material, environmental controls, systems, equipments, etc.), and coordinate analytical tests
- Ensure to obtain and/or keep up-to-date all product-related master documents (manufacturing documents, packaging instructions, specifications, etc.)
- Verify and approve executed batch documents and certificates of analysis prior to release
- Coordinate stability programme activities
- Revise validation protocols
- Verify and approve the packaging blueprints
- Follow up with individuals involved in the product manufacturing and packaging process
- Update and follow up on the training programme
- Comply with Duchesnay's established policies and procedures
- Perform any other related tasks.
Key Skills:
- Communication skills
- Rigour and thouroughness
- Sense of autonomy, initiative and responsibilities
- Team work skills
- Analytical thinking and judgement skills
Requirements:
- University degree in Science or College degree with minimum 3 to 5 years of relevent experience in the pharmaceutical industry
- Excellent knowledge of GMPs and technical knowledge of pharmaceutical methods and quality control concepts
- Knowledge of pharmacopoeia (USP, BP, EP, etc.)
- Knowledge of ISO 13485, an asset
- Experience with regulatory affairs, an asset
- Bilingual (French/English) oral and written
- Good knowledge of Microsoft applications
We offer a competitive salary with a whole range of fringe benefits. This permanent full-time position is available immediately.
If you are interested and have the required qualifications, send us your resume before September 24, 2010:
We thank all the applying individuals for their interest. Only selected candidates will be contacted.
