Cpl in partnership with our client SK Biotek are currently recruiting for a QA Team Lead to join their QA Operations Team on a permanent basis. Reporting to the AD QA Operations, the QA Ops Team Lead will be responsible for a team of people working closely with the business functions to provide QA support. This is an exciting opportunity to join a pharmaceutical company with over 50 years of API manufacturing experience.
- Provide compliance leadership to the QA Team and across the site ensuring the site and vendors operate to the applicable cGMP and international standards for our customers on a daily basis.
- Support the QA team in the effective transfer of NPIs in collaboration with the site cross functional team.
- Mentor and coach a highly skilled, professional quality assurance team to ensure batch release, product performance, product quality reviews, stability reviews and other cGMP documentation, including SOPs, policies, and manufacturing documentation are completed to the required standards.
- Ensure investigations and vendor non-conformances are robustly investigated with appropriate CAPAs and effectiveness review.
- Interact with customers through Quality-to-Quality and cross-functional forums to discuss investigations, campaign preparations and changes as required. Ensure that customer requests are completed according to agreed timelines.
- Contribute to the site Quality Council Process ensuring that appropriate metrics are in place for the effective monitoring of the quality system.
- Drive the development and implementation of new techniques, systems and initiatives to enhance the quality system on site. Champion continuous improvement with particular focus on right first time and lean methodologies.
- The QA Team Lead will be required to work on his/her own initiative as much as working as part of a team. As such excellent interaction, communication and presentation skills are necessary to be successful in the role. The QA Team Lead will be committed to continuous improvement, leading initiatives and working with members of the Value Stream to drive efficiencies and to assure compliance standards for the site.
- The successful candidate will hold a BSc or BEng in Chemistry or a science-related discipline, and should have at least 5 years’ pharmaceutical experience ideally in a QA role. The successful role holder will be able to demonstrate excellent time management and organisational skills along with a proven ability to multi-task.