Quality Assurance Supervisor

We have an exciting new opportunity for a QA Specialist with a well know multinational client of ours in the region. 

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 team 

Ensure 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 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 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: 

• A degree in chemistry or another relevant science subject with several years’ relevant experience in the pharmaceutical industry.

SKILLS: 

• Excellent organisational and time management skills (is organised and can prioritise demands).
• Strong communication skills: listening, written, verbal and interpersonal (ability to communicate effectively at all levels and with varying personalities).
• High attention to detail, high level of accuracy in all aspects of the position.
• Strong problem solving and analytical abilities.
• Drives and supports change and continuous improvement.
• Self-starter, positive attitude and motivated by the role and can motivate others.
• Strong work ethic and ability to meet assigned deadlines.
• Flexible and willingness to adapt with business requirements.
• Works to the highest professional, ethical and moral standards.
• Exercises discretion and confidentiality at all times.

EXPERIENCE: 

• 5+ years’ experience working in a quality function within a multinational pharmaceutical regulated environment.
• 3+ years people management experience
• Proven continuous improvement experience.
• Formal six sigma accreditation required (minimum Green belt certified but Black belt preferred).
• Project management; must have led projects if not formally trained in PM.
• Experience in managing/presenting in regulatory inspections is required.

KNOWLEDGE: 

• Good knowledge of cGMP especially Quality Systems.
• Regulatory requirements for APIs and Pharmaceutical products
• Application of six sigma, quality risk management and project management.
• Knowledge of validation is desirable.
• High level computer proficient e.g. MS Word, Excel, Power-point, Quality Systems, SAP.

To apply for this role please email your CV to siobhan.morrissey@eflexes.com