JOB PURPOSE 1. To drive the strategic implementation of management systems in Duopharma Klang's Manufacturing Division in ensuring expectations of the Business and Compliance objectives are met.
2. To coordinate multi-level and cross-departmental efforts to materialize Manufacturing System initiatives which are aligned with Manufacturing++ Strategy and Corporate Strategy.
3. To ensure company is operating in full compliance with NPRA rules and regulation pertaining to the management of Good Manufacturing Practices and ISO 9001 / ISO 13485 standards
4. To promote and uphold a culture of regulatory compliance with emphasis on pro-active compliance measure.
5. To lead, direct, advice, coordinate and manage all aspects of compliance improvement in production, engineering, material warehouse and finished goods warehouse.
KEY ACCOUNTABILITIES 1. To lead the identified roadmap in MS strategy and plan for the execution of the initiatives within time and cost.
2. To ensure no critical citations is obtained, and all CAPA satisfactorily closed in any regulatory audit at all times for Duopharma Klang's Manufacturing Divisions, consisting of Production, Engineering and Material Warehouses.
3. To continuously enhance the management system in the respective division and implement actions to close not only on regulatory compliance gaps, but also to exceed the trends expected in the Pharma industry.
4. To plan, organize and drive compliance improvement effort together with Compliance team, aimed to enhance cGMP practices in line with Company's Quality Policy.
5. To develop roadmaps and execution to achieve "audit readiness"
6. To prepare, review and approve relevant Quality and Technical documentation that forms part of the QMS system. This includes (but not limited to) procedures, protocols, reports, change controls, agreements, etc.
7. To lead and advice in quality Risk Management activities, including being the risk coordinator for all manufacturing related GMP risks
8. To lead, identify and coordinate rationalization plan of all critical procedures across different sites (only Manufacturing Division)
9. To lead, evaluate, plan and develop an effective documentation system which provides clarity and traceability; as per Data Integrity Policy.
10. To develop, maintain and upgrade in-house GMP Training program for Manufacturing's employees and to supervise the implementation of training program to ensure all new operation staffs are trained and evaluated before entering GMP work areas.
11. To ensure all preparation and non-conformances gaps are closed and prepping of the Manufacturing team for planned and unplanned major external audits (NPRA / TGA / ISO / etc).
12. To ensure all preparation and non-conformances gaps are closed and prepping of the Manufacturing team for planned and unplanned major external audits (NPRA / TGA / ISO / etc).
13. To assist external audit of outsourced activities, suppliers and service providers; to ensure the compliance level of the direct support to the Manufacturing division.
14. To lead, Coordinate and advice projects relating to automation and Industrial revolution 4.0 and any system related changes and improvement activities.
REQUIREMENT Bachelor in pharmacy, engineering, business, and any other related field of study
Possess Lean Six Sigma certification would be an advantage
Experience with Internal Auditor & Supplier Audit; ISO 9001
5+ years of working experience in manufacturing systems, manufacturing compliance, and manufacturing improvement process
Good understanding of production processes such as manufacturing in pharmaceutical, FMCG, and other manufacturing industries.
Excellent communication, management, and report writing skills.
Thorough understanding and ability to interpret regulatory guidelines
Good interpersonal and leadership skills
Good planning and organizing/management skills
Good communication and analytical skills
Good effort and initiatives
Good attitude and discipline
Integrity
Independent
Self-confidence
Conceptual and analytical ability
Achievement oriented