Objectives and Key Deliverables
Seeking a Quality Assurance Manager to work on a 6 month project (can be extended to 12 months) for a pharma company in Singapore.
Planned start date: 4th April
Please apply by 17 Feb to be considered.
QA Manager's Responsibilities:
• Lead the QA team including developing and communicating appropriate objectives, priorities and metrics for the QA team.
• Instill a culture of lean operations by reviewing existing QA work practices and reducing non-value added activities in a systematic manner.
• Ensure all process and operations remain in full compliance with Regulatory filings and submissions.
• Ensure the appropriate systems are in place such that the site operations meet or exceed the requirements of the company and the regulatory authorities for the quality of the products manufactured on site or by approved suppliers (lot disposition).
• Review and approve quality operations and production quality assurance reports and investigations for deviations from approved manufacturing processes or specifications.
• Review and approve laboratory investigations.
• Ensure equipment cleaning is reviewed and meets limits prior to release for use.
• Allocate department staffing and manage the utilization of facilities and equipment to ensure departmental objectives are met within budget guidelines.
• Support, promote and demonstrate corporate and PGS vision, values, and leader behaviors.
• Enhance knowledge of cGMP and current regulatory requirements for site technical staff.
• Coordinate Annual Product Reviews.
• Conduct performance assessment and development reviews of QA staff as part of the department development efforts.
• Degree in Science / Engineering or related field with at least 8 years of relevant experience of which 5 years in a managerial role.
• Experience in a pharmaceutical plant is preferred.
• Demonstrated record of successful interaction with global regulatory agencies (e.g. FDA, MHRA) and other internal and external auditing groups.
• Successful track record of continuous improvement, development, and/or implementation of best practices in quality operations or manufacturing.