Job Responsibilities:
Organize and administer the Singapore Operational Quality Unit/s to provide efficient, timely and reliable testing & inspection services and release in accordance with cGMP.
Accept/reject finished products, intermediates and raw materials as necessary. Assure that only those products which have met the established standards and specifications and have been assessed to be fit for purpose shall be distributed supported by appropriate CoA/CoC to meet market requirements.
Ensure the effectiveness of Cross Functional Investigation Board and to make decisions on the adequacy of investigations, root cause analysis and corrective and preventive actions. Responsible for decision making of all aspects of suitability of investigations associated with facility, process, equipment and analysis that may impact the safety, strength, purity, quality or identify of the material, ensuring patient safety through appropriate disposition of the products, intermediates and raw materials.
Ensure inspection readiness of the area with respect to all self inspections, internal and external audits within and external to the company. When required provide responses and timely follow up on relevant corrective actions an commitments made as a result of the inspections, communicating with FDA, Corporate Quality Assurance and other regulatory agencies concerned if necessary.
Represent the Singapore operation in dealing with quality assurance aspects e.g. Customer complaints, Annual product review, stability management, change control, Technical agreements, etc. Maintain the associated documentation in a GMP compliant manner, identifying trends to prevent recurrence, assure that proper corrective action are assigned and completed and that appropriate notification is made to all relevant parties.
Establish and maintain a good communication link with all internal and external customers on quality issues.
Provide QA support to all validation process optimization and process & analytical technology transfer activities for change control, new market introduction and new product introduction. Responsible for the review and approval of validation documentation for methods, process and equipment. Also provide quality decision-making / input as part of DCT teams or as site/department representatives.
Provide required support for departmental, site and corporate project activities as required.
Provide data for quality council and off site score cards in a timely manner.
Management of the preparation, review and approval of standards, procedures and specifications. Provide system for documentation control.
Provide support/guidance for the implementation and maintenance of corporate and GMP standards. Work with production and other support areas, e.g. engineering to assure that the facilities, equipment and operation are consistent with corporate policies, quality objectives and governmental regulations.
Ensure tan effective training system for the area and provide direct reports with appropriate training for both technical and soft skills through learning courses, job exposure and coaching and mentoring. Provide timely and effective staff performance appraisals.
Provide mechanism for assessment of performance measures and promotion of Continuous improvement culture in department.
Maintain and manage a budget at a level consistent with acceptable ethical drug manufacturing practices, enabling estimation of realistic staff and spending needs based on volume and cost of service.
Participate in SHE, Business Compliance, cGMP and all other compliance-related matters, where applicable.
Supervise and oversee Third Party Contractors, where applicable.
Any other tasks as and when assigned by Supervisors.
Requirements:
Bachelor Degree in a related Science or proven relevant experience in the pharmaceutical industry
5-7 years relevant quality control, quality assurance experience in a relevant regulated manufacturing environment, preferably pharmaceuticals
Good knowledge and application of GMP
Technically competent
Proven managerial/supervisory experience preferred
Ability to access impact and make decisions and takes accountability to work under pressure
Good time management skills
Ability to build, develop and lead a high performance team, good people management and team-working ability with people at all levels
Exhibits Good Leader Behaviours and interpersonal skills
Continuous improvement mindset
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