QA Specialist responsible for evaluating and reviewing clinical and commercial drug batches at Pfizer. Ensuring quality compliance and supporting manufacturing operations teams in Ireland.
About the role
- Quality Assurance Manager overseeing compliance and quality assurance for Sizewell C nuclear project. Building relationships within quality teams and ensuring regulatory compliance in logistics activities.
Responsibilities
- Provides leadership, direction, coaching and support to support all Wilson James activities so that the strategic objectives of the function can be delivered.
- Builds strong relationships within the SZC Quality team and seek to support them in delivering their objectives in a compliant way.
- EDRMS management for Wilson James (A-Site) and client (Teamcentre).
- To underwrite document governance and assurance for compliance and operational delivery.
- Maintaining the Wilson James SZC Quality Plan, ensuring regular reviews and updates.
- Oversees the day-to-day activity of their team, providing support and coaching where required.
- This includes process reviews on all activities to underwrite ONR compliant logistics.
- Assures compliance with the Quality Standards held by the business and proactively supports the business to be better.
- Generation of reports to highlight Business Performance (e.g. Board Report) via Head of Internal Audit & Assurance Manager
- Provide expert knowledge where required in regard to site activities.
- Planning and conducting internal audits, maintaining the site audit calendar.
- Hosting external audits (ONR/SZC)
- Managing corrective actions through Notify, ensuring all actions are completed in a timely manner.
- Provides input into both Client and Supplier PQQ where appropriate
Requirements
- Appropriate auditing qualifications (e.g. ISO9001 Lead Auditor)
- CITB H&S test pass certificate for Managers & Professionals
- Strong working knowledge of Quality Assurance, regulations, specific to the construction industry logistics activities.
- Proven Quality Management experience
- Proven experience of continuous improvement.
- Strong construction or engineering background.
- Excellent written and spoken communication skills, able to communicate at all levels.
- IT literate - Strong electronic communication, spreadsheet, and presentation skills.
- An understanding of the principles of equality and diversity in relation to visitors' and employee's
Benefits
- Salary starting from £63,000
- 8.5% bonus
- Travel and lodge allowance
- Working Monday - Friday
- 25 days annual leave plus Bank Holidays
- Life assurance scheme
- Company sick pay
- Pension Scheme 5% employer contribution
- Access to an industry leading Employee Benefits Platform offering lifestyle savings and discounts on most high street retailers
- a Reward and Recognition programme
- Employee Assistance Programme that provides a health and wellbeing support service
- As an employer of choice, we focus on wellbeing, training, and career progression
- Employee Referral Scheme
- Access to online GP service for you and your dependant
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