Role Purpose
- Reporting to QC Lab Manager.
- You will be responsible for the QC operational or system aspects of all analytical testing within the lab, responsible for leading, coaching and developing the lab chemists and analysts and ensuring that chemical testing is performed in a safe and reliable manner to support manufacturing operations across all shifts.
Responsibilities
- Write, approve and review working procedures for the laboratory.
- Conduct laboratory investigations and ensure all follow up actions are completed make decisions based on scientific and logical reasoning on behalf of the laboratory manager when required.
- Keep up to date on the regulations/ compliance to provide support and guidance to the team to ensure appropriate quality oversight in quality control operations.
- Know the processes and procedures, including the principles and practices of good data management (ALCOA), and be able to guide, advise and coach their teams.
- Be accountable for the Good Data Management and Data integrity understanding and performance of their team.
- Participate and lead site teams/ projects e.g. LIMS, CDS, Safety, continuous improvement, Analytical Method Transfer Exercise.
- Review product and raw material results. Performs quality review of completed test records and release of raw materials, solvents and packaging materials.
- Work closely with key QA, Production, Engineering and EHS personnel to support them in laboratory testing and troubleshooting when required.
Supervisory Duties
- Ensure all direct reports receive required cGMP, GLP, EHS and role related training related training required to work safely and in compliance with regulatory requirements and as defined by their learning plan. Provide coaching and mentoring for professional development of staff.
- Engage and inspire their teams on performance expectations and coach the team to meet those expectations using Coaching Skill principles.
- Supervise QC personnel in troubleshooting laboratory equipment failure and laboratory investigation.
- Train fellow colleagues on written procedures pertaining to equipment operation, test methods and general laboratory operation.
- Supervise the team of analyst and ensure that testing documents (e.g. laboratory notebooks, test methods) accompany the analyst at the same time when testing activities are performed. Ensure analyst follow the ALCOA principles.
- Effectively monitor the actions of their team. Ensure an active daily presence in the GMP work area to observe the work activity and practices within their role responsibilities.
- Be available to their direct reports for real time escalations of any concerns or support needs.
Key Attributes
- Commitment to work and positive influencer/ role model/ motivate others for overall operational excellence.
- Be observant, investigate and report actions or behaviors that may negatively impact the desired outcome of the GMP process or activity.
- Be a role model to support a positive compliance culture.
- Be vigilant for potential actions or behaviors that could result in breaches of GMP compliance or Data Integrity principles.
Qualification and experience
- Bachelor or Master or PhD degree in Science Chemistry or Life Science relating to Chemistry, Pharmacy, Pharmaceutical Science or Microbiology or a related science.
- Not less than 5 years' experience working in a chemical laboratory, preferably within the pharmaceutical industry and with experience in managing/ supervising small groups of laboratory analysts.
- Proven track record in people management and in supervisory role.
Tan Cheu Hoon, Fenny
EA License No.: 02C3423
Personnel Registration No.: R22105896
