Job Description

JOB SUMMARY:
To execute quality compliance relevant activities and maintain site Quality Compliance Management systems under guidance from Compliance Manager, to ensure site compliance with GMP requirements, corporate policies and procedures are maintained.

This position will play an important role in QA Compliance team, to ensure adherence and effectiveness of site’s self-inspections, identify opportunities for continuous improvements of site quality system. To ensure timely delivery of our commitment to Regulatory and Clients. Work as an expert in Quality Risk Management, to ensure Quality Risks are identified and properly mitigated.

Further, this role will include other supporting activities from quality compliance perspective, to make sure site practices meet cGMP and corporate requirements. Such as providing quality oversight to Qualification and Validation, supplier management, complaint handling, Quality culture establishment and Practical Process Improvement etc.

RESPONSIBILITIES:

• Ensure the safety message that the first goal of all employees is safety is implemented and lived throughout their organization and bolster this throughout the facility as possible.
• Execute site self-inspection program, to ensure site practice compliant to cGMP and corporate policies, and work on continues improvement of site compliance. It includes but not limited to: Develop site self-inspection annual plan, coordinate and participate site self-inspection, perform periodic review and trend analysis for this program, and also develop site GMP auditors.
• Coordinate and complete Inspection readiness activities to ensure site ready for both client and regulatory audits at all times.
• Participate in hosting client and regulatory audit, responsible for timely and effective execution of external audit commitments. Interact with SMEs in all functional areas of the site to manage their response to any findings and their timely commitment to address those findings within CAPA and other quality systems.
• Monitor local regulation updates, manage gap analysis and comments feedback at site level, ensure site practice compliant with regulation requirements.
• Support site management review process, collect quality data, analyze compliance performance trend, be able to identify and manage the metrics, and responsible for continues improvement.
• Responsible for local filing business and communication with local regulations.
• Provide quality oversight on Qualification/Validation activities, to ensure they meet cGMP and PQS requirements. it includes but not limited to define site Qualification/ Validation strategy, review and approve qualification/validation document.
• Provide quality oversight on site supplier management program, manage Quality Agreement and supplier change control, participate in Material Certification and Supplier selection/evaluation as quality representative.
• Administer site Quality Risk Management system, maintain site Quality Risk Register, to ensure Quality risk could be identified and appropriate mitigated.
• Participate in cross- functional teams on continuous improvement projects to further enhance site quality performance and client experience.
• Engage in quality initiatives to continuously elevate the quality culture.
• Execute any other related work assigned by company.

• Bachelor’s Degree in Life Sciences or Chemical/Biochemical engineering, Pharma related Scientific Area.

• At least 5 years of Quality experience in pharmaceutical.
• Experience performing audits, professional Auditor Certification preferred but not required.
• Experience in hosting regulatory inspection and client audits.
• Qualification/Testing experience or working knowledge with manufacturing and laboratory equipment, cleanroom, or critical supporting systems.
• Experience of QRM tools such as FMEA and Quality Risk Register.

• Practical knowledge in GMPs and Regulatory Compliance
• Strong interpersonal and communications skills
• Ability to generate and interpret data from various sources
• Proficient in MS Office application
• Ability to work in a team environment to meet goals and timelines
• Continuous improvement mindset.