Kerja Sepenuh Masa, Quality Assurance Manager di Winwa Medical Pulau Pinang - Maukerja

Job Highlights

Career Growth and Development Opportunities

5 working days

Growing Pharmaceutical Company

Responsibilities:

·        Drive the design, implementation and continuous improvement of the organization’s Pharmaceutical Quality System (PQS) to ensure it is in compliance with cGMP in line with current PIC/S GMP Guideline.

·        Oversee harmonization of quality processes globally, ensuring scalability and efficiency while maintaining compliance with GxP standards.

·        Enforce the Quality Assurance (QA) systems within the organization.

·        Establish and execute internal and external risk-based audit programs ensuring readiness for regulatory inspections and audits.

·        Lead and mentor a team of quality professionals, fostering a high-performance, collaborative environment.

·        Identify, train and qualify auditors to support the organization’s audit programs.

·        Oversee vendor and partner qualification process to ensure they meet organization’s quality standards and maintain compliance with GxP requirements.

·        Manage raw material qualification and packaging material qualification.

·        Manage the critical facilities and utilities (Purified Water System, HVAC and Compressed Air System) qualification, re-qualification, monitoring and maintenance program within the organization.

·        Manage the documentation control system, change control system for system related changes and the CAPA system within the organization.

·        Lead the cleaning validation team and equipment qualification team.

Requirements:

·        Degree / Master qualification in Pharmacy, Pharmaceutical Science or equivalent.

·        Good knowledge of pharmaceutical compliance guidelines.

·        Experience within pharmaceutical or healthcare industry preferred.

·        Excellent presentation skills in both written and oral forms.

·        Analytical thinking, problem solving and decision-making skills.

·        Leadership, networking, influencing and negotiation skills.

·        Analytical skills and experience with MS Office.

·        Demonstrated maintenance of highest ethical standards.