- Provides Quality and Compliance inputs and advice regarding GMP considerations, and takes a leadership role in ensuring compliance to appropriate regulations and corporate standards for a new product introduction.
- Partners with other QA functions to assure consistent professional and appropriate QA validation support across project and audit needs.
- Supports Quality systems including, but not limited to, Change Control and Validation.
- Provides Quality and Compliance expertise for all IPT and site compliance initiatives
- Supports Quality and SHE stewardship activities
- Serve as representative for Quality Assurance and compliance program for IPT for change control and validation activities.
- Serves as member of project team with participation in the applicable forums, providing GMP compliance advice and guidance to customers, to achieve continuous quality improvement and effective quality controls.
- Reviews and approves Change Control (Equipment, Automation, Process)
- Approves cGMP documentation, including SOP, Job Aids and procedures as Quality approver.
- Supports IPT compliance programs
- Develops a continuous improvement framework within the Quality team, identifies and implements projects and improvements, actively supports site improvement programs
- Apply knowledge of local and global compliance requirements, regulations and quality guidelines to all aspects of product specifications, manufacturing processes, warehousing/ distributions system and lab functions.
- Apply appropriate knowledge of compliance requirements, HA and regulatory authority expectations and business intelligence to support development of and amendments to internal quality policies.
- Able to proactively respond to new regulation and global/emerging market changes to identify the implications of these regulations on applicable quality standards. Use Knowledge of HA and regulatory authority expectations to uphold behaviour that maintains company's compliance and to ensure product quality standards are met.
- Possess 7-9 Years of relevant experience in a quality assurance and other function (e.g. operations, technical, etc) in pharmaceutical manufacturing environment, supplying to highly regulated markets such as FDA, EMA, PMDA etc.
- Possess good knowledge and understanding of GMP and application of pharmaceutical regulatory requirements.
- Prior experience in a sterile manufacturing experience preferred.
- Experience in Quality Risk Management.
- Experience in roll out of corporate automation system.
- Good knowledge of system lifecycle management.
- Problem Solving skills
- Good interpersonal skills.
- Preferably with Bachelor Degree in Science/ Life Science, IT or Engineering or proven relevant experience.
If you have the relevant skillsets, please send in your updated CV in word format to firstname.lastname@example.org.
We regret only shortlisted candidates would be contacted.
Sherry, Yew Koon Ng EA License No.: 02C3423 Personnel Registration No.: R1657259