Quality Assurance Supervisor
Provide leadership, direction, and expertise with regards to all Quality & GxP/GMP Compliance activities at the site. Provide day to day leadership, direction, and support to the Quality Assurance. Acts as deputy to the Director of Quality as and when required.
- Full oversight of site Quality Management System, including;
- Batch Release, Deviation Management, Auditing, Change Control, Complaints, GxP/GMP, CAPA System, Quality and Technical Agreements, Vendor approval, Product Quality Review
- Facilitation of cross functional teams in the performance of quality risk assessments
- Review and/or approval of completed Quality Risk Assessments
- Management of QRA’s as life cycle documents.
- Operational Excellence
- Champions Operational Excellence culture within the QA team and leads/drives projects to support compliance and efficiency projects across the site from QA perspective
- Delivery of site projects including system integration projects, support of new product introduction and associated compliance activities.
- Participate in Global compliance initiatives as requested.
- Assist the Director of Quality in the management of regulatory inspections and corporate audits at the site and lead customer audits as required.
- Influence site personnel at all levels to develop/maintain compliance culture whilst championing a collaborative approach to achieving quality goals.
- Any other reasonable job related duties that may be required from time to time.
People Management Responsibilities
- The Supervisor is responsible for supervising and developing people within their team. This entails all people management aspects of the role, including;
- Act as first point of contact on matters concerning your direct reports.
- Communication; keep your direct reports and others (as required) informed on relevant matters and ensure key messages and updates are communicated in a consistent and timely manner.
- Ensure direct reports understand their roles, have adequate work and clear objectives, and are performing to expected levels.
- Ensure direct reports are fully trained, training requirements/plans are met, and prioritises training attendance.
- Acknowledge and recognise good performance and contributions from operations team members, in a timely manner.
- Provides one-on-one support (coaching/mentoring) and feedback where required.
- Conduct performance appraisals with direct reports on time and as prescribed.
- Proactively manage any conduct or performance issues appropriately and in a timely manner, and in accordance with the Company disciplinary procedures.
- Ensure Company work rules and contractual agreements are consistently applied, including; adherence to agreed working hours, start and finish times, leave rules, timekeeping, break times etc.
- Deal with conflict or grievances which may arise and seek to address them at their point of origin, where possible, and in accordance with relevant policies and procedures.
- Exercises discretion and confidentiality at all times, in relation to business, management, and employee matters.
- Any other relevant people management related activities.
- Must hold at least a Degree in Chemistry or another relevant science subject
- Must hold Internal Auditor Certification