Sr. Quality Assurance Associate - Projects

Bayer  •  Mississauga, ON

8 - 10 years experience  •  Business Services

Salary depends on experience
Posted on 11/28/17
Mississauga, ON
8 - 10 years experience
Business Services
Salary depends on experience
Posted on 11/28/17

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
(GMP) regulations.

KEY RESPONSIBILITIES:

 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.

DESIRED QUALIFICATIONS:

  • 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

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