Senior QA Manager
Job Description
Provide QA oversight for Qualification and Validation activities at Manufacturing site with the following core responsibilities:
- Setup/be part of the QA validation team to support all aspects of qualification and validation program, including qualification & re-qualification of process and testing equipment, manufacturing process, QC testing, shipping, etc.
- Develop, review and approve validation and qualification strategies for manufacturing facility, processes, cleaning, shipping and equipment, including supporting risk assessments.
- Provide QA expertise to assess impacts and support investigations, deviations, CAPAs related to validation / engineering processes.
- Provide oversight for validation / engineering related cGMP documents including, but not limited to validation plans, SOPs, work instructions, templates, guidelines, protocols, summary reports and ensure consistency and compliance with regulatory requirements.
- Review and approve facility and equipment related change controls, including the assessment for equipment criticality, calibration / PM program.
- Create Validation Master Plan and ensuring that the Company's Validation Master Plan is up to date, maintaining the validation life cycle of the manufacturing facility.
- Manage site validation documentation program, validation vendor management and maintenance.
- Provide leadership and guidance to staff on qualification / validation matters. Directs efforts to ensure efficient and effective systems are maintained and continuously improved.
Requirements
- Degree and above in relevant subject
- At least 5 years of experience in Quality Assurance and / or Compliance, including oversight for validation projects
- Extensive knowledge of cGMP requirements, with working knowledge and understanding of Validation, Production, Quality Control requirements and activities
- Strong working knowledge of US FDA and other equivalent regulatory requirements.
- Mastery and knowledge of quality principles and cGMP guidelines.
- Good understanding of validation principles and critical process parameters.
- Good people management skills with ability to work cross-functionally.
Please send your resume in WORD format by clicking the apply button below or contact Jochen Surrey on +65 6701 1516 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1878834 (Jochen Nico Surrey).
