Our client is a global leader in the pharmaceutical industry, dedicated to improving health and well-being through innovative medicines and healthcare solutions.
They seek a Regional Quality Operations Specialist in Singapore to join the Quality Assurance team in ensuring quality compliance with regulatory standards and upholding high-quality pharmaceutical, medical devices guidelines and requirements.
Key Points:
- New headcount with growing, reputable pharma MNC
- 5-day work in CDB area with hybrid work arrangements, near MRT
- Overseas travelling opportunities with attractive salary and perks
Responsibilities:
Uphold quality standards and activities of regional external/contract manufacturing organisations, ensure adherence to relevant international regulations, guidelines and industry practises alongside company compliance requirements.
- Quality oversight of Contract/External Manufacturers (CMO/EMO)/3rd party logistics providers, collaborate with internal teams to review CMO/EMO’s activities and performance such as OOS/NCR/ Deviation and CAPA, Change Control and routine stability testing monitoring, on time and in compliance to GMP and applicable standards
- Quality oversight of our product portfolio; ensuring the necessary quality activities, assessments, and monitoring are being effectively conducted by network of manufacturing and distribution partners
- Ensure complaints are managed and resolved according to compliance requirements of regulations and SOPs within the required timeframes
- Handle product release process from batch receipt, while minimizing recall incidences or critical product quality issues
- Manage change control processes, and action on individual change controls within the defined target dates and in compliance to GMP and iNova SOPs
- Manage individual deviations, NCR & CAPA processes, and action on them in compliance with GMP and organization SOPs, and align timeframes to business needs, to minimise recall incidences or critical product quality issues
- Prepare, review &/or authorise Quality documents and procedures as defined e.g., SOPs, WIs, forms, PQR, Deviation and Quality investigation reports
- Maintain and manage Quality Management System (QMS) e.g., Change Control, Deviations & CAPA, Customer Complaints, including associated Metrics as part of performance monitoring
- Support due diligence checks for new external contract manufacturers, new products; support internal and external audits as required
- Support the maintenance and improvement of the quality system.
Requirements:
- Bachelor's degree in a Chemistry, Pharmacy, or a related discipline; preferred Science or Engineering.
- Minimum of 5 years of experience in pharmaceutical or medical device industry, including 3 years in relevant regional quality assurance roles.
- Experienced in Quality Assurance, especially with experience managing overseas EMO/CMO/third party manufacturing experience is highly preferred.
- Strong GMP, Computer system validation, deviation management, CAPA, change control and documentation management in pharmaceutical / medical device MNC environment.
- Demonstrate pro-activeness to drive results even amidst crises and ambiguity, thriving in fast-paced and dynamic environments.
- Successful proven track records of implementing continuous improvement projects with regional teams to enhance overall business operations.
- Possess strong cross-functional collaboration skills and adept stakeholder management capabilities. Skilled in building and maintaining relationships at all levels, both internally and externally.
NOTE: Position title may change based on candidate's experience, qualifications, and company structure at time of offer. This is to ensure alignment with candidate and organizational needs.
The selection process involves careful consideration, and only shortlisted candidates will be contacted. We extend our gratitude to all applicants for their interest and effort in applying.
Principal Consultant: Amber Chen | Registration Number: R22108633 | EA License Number: R1110404
