Quality Assurance Specialist (9 Months Contract, Renewable)
Our client is a US MNC and a pioneering leader in the Pharmaceuticals industry. They are currently seeking a QA Specialist. The successful candidate will be in partnership with the Quality Manager, providing Quality and Compliance inputs and advice regarding GMP considerations, and taking a leadership role in ensuring compliance to appropriate regulations and corporate standards.
- Support Quality systems including, but not limited to, Validation, Deviation Management, and Change Control.
- Provide Quality and Compliance expertise for all IPT and site compliance initiatives
- Support Quality and SHE stewardship activities
- Lead and drive site Quality culture.
- Serve as representative for Quality Assurance and compliance program for IPT, which may include Deviation Management, Change Control, Equipment and Process Validation and other quality initiatives.
- Serve 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.
- Proactively identify analyses and leverages quality indicators and data to identify potential trends and risks to address and complete risk-based QA assessments and to support the implementation of associated risk mitigation strategies
- Review and approve investigation documents. Coach and guide investigation team to ensure investigation is thoroughly conducted and meet the standards set in the SOP.
- Review and approve Change Control (Equipment, Automation, Process).
- Support walkdown to ensure compliance and maintain high level of ICSL, LROT, iOTIF.
- Approve cGMP documentation, including SOP, Job Aids and procedures as Quality approver.
- Supports IPT compliance programs.
- Develop a continuous improvement framework within the Quality team, identify and implement projects and improvements, actively supports site improvement programs.
- Ensure timely closure of deviation and laboratory investigations, change controls, and protocols.
- Makes decisions - guided by policies and procedures - that impact the department ability to meet performance objectives (i.e. Product disposition).
- Bachelor's Degree in Science / Life Science, IT or Engineering or proven relevant experience.
- 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.
- Good working knowledge and understanding of GMP and application of pharmaceutical regulatory requirements.
- Validation and Sterile manufacturing experience preferred.
- 0 - 7 years of relevant experience.
- Strong communication skills.
- Able to work independently and in a team environment.
- Meticulous with high integrity.
- Strong organizing and time management skills.
- Positive attitude and self-motivated.
If you're interested, please send in your application with your detailed and updated resume to Tammy Chew Wen Hui (R1877573) at email@example.com.
Tammy Chew Wen Hui EA License No.: 02C3423 Personnel Registration No.: R1877573