QC Supervisor (9-12 month contract) - Pfizer Little Island
Reporting to Quality Control Team Leader, an opportunity has arisen for a QC Supervisor role (9-12 months) within the Quality Operations Team at Little Island API site.
The QC Supervisor role is to maintain an efficient and compliant Quality Control function within the facility. The role incorporates responsibility in the areas of Incoming Raw Materials, Intermediates, API testing and Technical Transfers (AMTE) as required. The supervisor is responsible for the timely and accurate testing of materials amongst the team of QC analysts whilst maintaining cGMP and relevant EHS standards. The role requires the building of excellent peer relationships within and outside of the QC department
The key responsibilities associated with this role include but not limited to:
- Ensures that all materials (raw materials, intermediates, finished products) are sampled, tested and released in accordance with the relevant SOP in compliance with ICHQ7, regulatory specifications and Pfizer Quality Standard requirements.
- Plan, organize and ensure stability sample analyses are undertaken in accordance with stability program
- Effective liaison with other teams on site to ensure efficiency of throughput of samples and testing using standard work processes to support efficient analysis turnaround to meet the shipping plan.
- Ensure effective investigation are completed using M1 and PHP tools and close out of Analytical Laboratory Investigation reports (LIR’s) including implementation of CAPA’s in a timely manner.
- Ensure the QC Analysts are adequately developed and trained to perform their duties. Maintaining an ‘Key Analytical Skills’ training program with particular focus on broadening the skills base and technical ability of all QC analysts.
- In conjunction with QA Calibration Coordinator and QO Systems/gLIMS Coordinator ensures necessary maintenance, service, calibration and qualification (in-house and external) of all QC laboratory instruments and systems is performed as per schedule. Introduce new equipment as necessary for AMTE’s for product transfers.
- Ensures all laboratory supplies (chemicals, hardware, glassware, consumables) are purchased, safety stored, and stocks maintained at a level which supports all testing requirements.
- Maintaining a strict code of conduct with regard to cGMP, safety and housekeeping in the laboratory in accordance with Safety and Quality Excellence Commitments.
- Promoting an environment of continuous improvement and Integrated Manufacturing Excellence within QC.
- Be cost focused and support budget within area.
- Support other activities within the QC Department as required.
Qualifications (Training, Education & Prior Experience):
- An appropriate third level qualification (Degree) in Analytical Chemistry, Chemistry or related discipline.
- 5 years previous experience in a GMP regulated manufacturing environment, preferably in a laboratory environment.
- Proven supervisory experience in a relevant technical role in a pharmaceutical/healthcare laboratory is preferred.
- The ideal candidate will be a self-starter with the ability to work on their own initiative and lead a team; and be responsive to changing and demanding needs.
- Excellent ability to deliver results, with strong interpersonal, communication and influencing skills.
- Good organizational and time management skills.
- Knowledge of API regulatory requirements
- Have a successful track record of continuous improvement and development / implementation of best practices in Quality Operations or manufacturing
- Given the importance on leadership of continuous improvement in this position, relevant qualification(s) in Six Sigma and/ or Lean would be desirable as well as demonstrated knowledge of GMPs, and Operational excellence tools, inspectional trends, data management principles, industry quality assurance/control practices and systems.
The following Leadership behaviours will be important to the role:
- Be ambitious to Thrive not just survive.
- Swift Decision making
- Demonstrate a flexibility and agility to fit any future business needs.
- Be proud of our business treating it as our own.
- Be a critical and strategic thinker
- Demonstrate internal and external collaboration.
- Demonstrate an entrepreneurial mind set and taking thoughtful risk.
- Inspire and empower others to continuously improve.
- Show and promote a tenacity to be a completer finisher.
The Behaviours are also critical for the role:
- Decisive – Manage complexity to make timely, informed decisions
- Focused – Develop impactful short- & long-term solutions for our customers & patients
- Connected – Collaborate with others to accomplish shared goals
- Inspiring – Motivate and develop self and others to move the business forward
- Courageous – Consistently demonstrate accountability in the face of challenges
- Resilient – Respond to change with agility and optimism and innovation