We have an immediate opportunity with long established Pharma client in the region for Quality Assurance Supervisor to join their team.
JOB PURPOSE:
Provide day to day leadership and support to the QA team to ensure that batch release, quality compliance, management of the site QMS, audit readiness and quality improvement site goals are achieved. Champions’ and leads continuous improvement within QA team. Oversee implementation of QA projects within specified timelines. Act as deputy to QAV Director as required.
PRINCIPAL ACCOUNTABILITIES:
Oversight of site QMS including:Batch release to meet scheduled targets, Deviation management, Auditing, Change control, Complaints, CAPA system, Quality and Technical Agreements, Vendor approval, Product Quality Review
Management of QA teamEnsure the QA team meets its objectives and supports overall business and corporate objectives. Responsible for appraisal performance reviews for QA team, coaching, development and cross-training of team members. Engages with all functions, encourages and supports collaborative approach to meeting QA objectives.
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 CI culture within the QA team and leads/drives multiple projects to support compliance and efficiency projects across the site from QA perspective.
Project ManagementDelivery 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 QAV Director 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.
QUALIFICATIONS/EXPERIENCE:
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