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Operations Quality Manager
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Quality Assurance Specialist - Operations Role
">This role is a critical part of ensuring compliance and execution of site operational activities.
">The Rathdrum Site Quality Operations Lead will serve as a partner alongside other stakeholders to guarantee the site is permanently inspection ready.
">Main Responsibilities:
">- ">
- Ensure that GMP activities are in compliance with regulatory, corporate and site procedures.">
- Provide in-plant/on-the-shop-floor support and guidance for GMP product quality assurance and compliance for Manufacturing Operations, Laboratory Operations and Warehousing activities.">
- Review executed Batch Records and Cleaning Records as per site procedures.">
- Quality review of SOPs, EOPs, Change Requests, Protocols, Reports, etc.">
- Quality business partnership for PPQ, CPV and APR activities, partnering with GMT, Laboratories, Operations and Regulatory to ensure successful transfer and validation of processes.">
- Support in ensuring compliant systems and processes are in place, validated and executed as intended.">
- Serve as a quality culture role model and instill a strong quality and compliance culture across the site.">
Requirements:
">- ">
- Undergraduate degree in pharmaceutical, biological or chemical sciences.">
- Relevant advanced degree preferred.">
- 5+ years relevant experience in Pharmaceutical and/or Animal Health industry, with a current knowledge of cGMP's and regulatory guidance required.">
- Significant experience in Equipment Commissioning/ Qualification, Cleaning Validation and Process Validation is desirable.">
- Recognised LSS Qualification (Yellow belt, Green Belt, Black Belt) desirable.">
Benefits:
">A competitive salary, bonus, 25.5 days holiday per annum plus public holidays, a defined contributory pension plan, private medical insurance for you and your family and empowered flexible working.
"]}