Job Summary

This role provides quality oversight of plant operation and laboratory processes to ensure adherence to cGMP requirements, regulatory requirements, corporate policies and established procedures. This position is responsible for promoting and maintaining regulatory standards compliance, supporting continuous improvement initiatives, and driving data integrity programs to strengthen quality systems and operational excellence.

Essential Duties and Responsibilities

• Support in maintaining compliance with cGMP standards within the laboratories.
• Provide GMP support for activities such as method validation, method transfer, instrument qualification, and verification of compendial test methods.
• Provide technical guidance on calibration of analytical instruments, validation of Excel spreadsheets, and implementation of computerized systems.
• Perform data audits and periodic reviews of laboratory test results, electronic raw data, laboratory notebooks, computerized systems, and Excel spreadsheets to ensure compliance and data integrity.
• Oversee proper administration and timely completion of cGMP processes, including
  • On-time review of procedures
  • Guide internal and external audits, including audit CAPA tracking and on-time completion
  • Oversight of OOS and Deviations to ensure compliant and timely closure
  • Provide training on GMP-related topics
  • Provide GMP support to ensure proper completion of instrument qualifications, change control, method transfers, etc.
• Support and drive data integrity initiatives in collaboration with global teams.
• Perform annual product review.
• Involve in A3 investigations, root cause analysis, CAPA management and CAPA effectiveness. Ensure CAPA or corrections are closed timely.
• Manage the Change Control process, including reviewing and processing change requests within SAP, monitoring and reporting change control trends, and supporting product disposition decisions to ensure compliance and risk mitigation. Responsibilities also include scheduling and coordinating local Change Control Review Board meetings, chairing the sessions, and preparing meeting minutes.
• Manage the product monitoring activities, including planning review and statistical trending of test data, ensuring timely review and documentation.
• Support plant document control system, including review, approval, issuance, and distribution of controlled documents, ensuring compliance with regulatory and QMS requirements.
• Conduct GMP orientation training for new employees to ensure awareness of quality and compliance requirements.
• Prepare and analyze Quality System metrics related to change control and data integrity, ensuring timely reporting.
• Support technology transfer projects to ensure quality requirements are defined and implemented effectively, if required.
• Lead and/or participate in product quality and quality system improvement initiatives.
• Lead and/or participate in contamination control strategy initiatives and shopfloor audits.
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Perform any other duties as assigned by the QA Manager

Education

• Bachelor’s degree or equivalent experience in Engineering or Science or related discipline.

Preferred Knowledge, Skills and Abilities

• Working knowledge of ISO 15378 and ISO 9001 or equivalent quality standards.
• Good knowledge of cGMP requirement and quality mindset is an advantage.
• Good understanding of Annex 1 requirement is an advantage but not required.
• Effective communication and interpersonal skills
• Good analytical and project management skills