QA Team Leader

Description Overview

In this role you will be responsible for the management of a team of QA Officers, including work planning, personal development, objective setting and performance appraisals

You will work as part of a cross skilled team to ensure compliance with regulatory and company requirements / standards by coordinating and managing key site Quality Management Systems, including CAPA, Change Control, Customer Complaints, Internal Audit, and Product Quality Reviews.

Support corporate, regulatory and customer audits.  

Scope of the Role

Support team members in achieving daily and long-term business goals, including site strategic objectives:

• Monitor and manage progress and performance and provide timely feedback through regular review sessions
• Support direct reports in identifying and executing individual development plans
• Maintain flexibility and engagement through rotation of roles and adequate cross-skilling
• Complete performance appraisals, including setting SMART objectives

Management of Quality Systems including:

• CAPA, Customer Complaints, Change Control, Internal Audit, and Product Quality Review.
• Act as a site Subject Matter Expert and System Administrator
• Maintain ongoing alignment with EU GMP and site SOPs
• Maintain databases, collate metrics, provide support and coaching to system users, establish and implement process improvements, liaise with internal and external customers.
• Ensure adherence to Key Performance Indicators, including schedule adherence and Right First Time.
•  Provide support to QPs and Head of Quality where required
• Support the management of external audits
• Lead and / or participate in site CI projects that will drive improvements in efficiencies, effectiveness and compliance

Experience Required

• Minimum 2 years’ experience within the pharmaceutical/healthcare industry.
• Must hold a degree or equivalent qualification.
• Demonstrate knowledge of pharmaceutical legislation and a good understanding of GMPs.  Compliance based focus – performance against regulations and reasonable customer expectations, corporate and internal standards.
• Good technical report writing skills.
• Effective communication – written and verbal – can convey information positively, succinctly, objectively to a variety of audiences.
• Must be proficient in computer software programmes such as word and excel.
• Proactively identifies gaps, issues, and opportunities for improvement, offers solutions and works with colleagues to collate, review and implement the best plan.
• Team player - can work as part of a team to find win -win solutions to issues.  Builds relationships with senior personnel, peers and subordinates effortlessly, to foster excellent team working.
• Completer finisher – focussed drive to identify tasks / projects and execute to a high standard within a timely manner.
• Ability to organize workload to ensure that commitments are seen through to the end, fully documented.