Collins McNicholas

Quality Assurance Supervisor

JOB PURPOSE:

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.

PRINCIPAL ACCOUNTABILITIES:

  • 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

Risk Management

  • 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

Project Management

  • Delivery of site projects including system integration projects, support of new product introduction and associated compliance activities.
  • Participate in Global compliance initiatives as requested.

Compliance

  • 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.

QUALIFICATIONS:

  • Must hold at least a Degree in Chemistry or another relevant science subject
  • Must hold Internal Auditor Certification

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