Senior Manager, QA Validation

Proclinical is working with a Clinical Stage biotechnology company that is seeking a Senior Manager, QA Validation to be based in Singapore on a permanent basis. This Senior Manager, QA Validation will provide QA oversight for Qualification and Validation activities at the company's Manufacturing sites.

Job 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.
• Participate in continuous improvement efforts in quality systems through the evaluation of trends in key performance indicators, audit and stakeholder feedback, and corrective / preventive actions.
• Provide support as needed in the regulatory audits / inspections or meetings.
• Perform other ad-hoc duties as requested by manager / supervisor.

Skills and Requirements:

• Degree and above in Cell biology/ Biotechnology/ Microbiology/Biomedical Science/ Biochemistry or Science related field with at least 5 years of hands-on experience in GMP-regulated cell therapy / biologic product manufacturing industries
• At least 3 years of experience in Quality Assurance and / or Compliance, including oversight for validation projects across the various validation activities from initial planning stage up to the eventual report summary stage.
• Extensive knowledge of cGMP requirements, with working knowledge and understanding of Validation, Production, Quality Control requirements and activities preferably in equipment / process validation, shipping validation, QC method validations, facility qualifications, etc.
• 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.
• Ability to identify problems, troubleshoot and complete or coordinate corrective actions.
• Strong planning and prioritization of activities for self without supervision.
• Ability to write & communicate effectively in a professional manner with peers, management and other functional groups.
• High attention to details, well organized and can effectively manage multiple projects.
• Good people management skills with ability to work cross-functionally.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Martin Grindrod on +65 3159 1292 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

R1433761

EA13C6865