BRIEF DESCRIPTION OF POSITION:
Performs Quality and/ or Compliance functions for all Bayer Inc. products and systems, as
defined by Standard Operating Procedures (SOPs) and Good Manufacturing Practices
Provides BHC Divisions Projects Support to Managers and or Manages assigned projects for:
• Product launches,
• Manufacturing or packaging sites transfers
• Products line extensions
• Products formula improvement initiatives
• Test method validation or transfer
• Assembly of product master production documents
• Review Manufacturer documents such as:
• Raw Materials Specifications
• Certificate of Analysis and Certificate of Compliance
• Finished product test methods and test methods validations
• Stability Protocols and summary reports
• As required manufacturing and packaging validation protocols and summary reports
• Review and approval of products printed artwork
• Initiate, Assess and approve Change controls for assigned projects, artwork and third party packaging procedures.
• Evaluate new product or expected product changes stability protocols and summary reports
• Where involved with third parties assess and present deviations and non-conformances to management,
• As required provide support during internal and external audits,
• Adhere to local and global standard operating procedures, directives and policies.
• Identifies product or document deviation or non-conformity to responsible QA staff, and provides support for resolution.
• Develops and maintains all quality documentation in compliance with corporate and regulatory requirements.
- Has strong GMP level knowledge of Drugs, Natural Health and Medical Devices regulation
- Has technology knowledge and experience of pharmaceutical products manufacturing and packaging
- Knowledgeable of requirements for drug establishment and site licensing
- Works with limited supervision
- Operates autonomously detecting and anticipating problems, and works together with supervisor to define solutions.
- Proposes changes to local procedures based on current practices.
- Has proficient knowledge of computers software.
- Post Secondary College Diploma/ Certificate or (preferred) University Degree in Science Related Field
- 3-5 Years’ Experience: in Managing QA related Projects such as new product launches, Manufacturing and packaging site transfers, product reformulations.
- 7-10 Years’ Experience: in QA/QC , Pharmaceutical manufacturing and packaging