Northwich, Cheshire, North West, United Kingdom Hybrid / WFH Options
Dechra
Ensures that there are robust processes in place for the review and release product for GLP and GCP studies. Ensures appropriate quality oversight of GMP activities performed by the Product Development teams at Dechra or CDMOs and contract laboratories. This may include review and approval of protocols, reports, methods, master more »
Literate - Experience and knowledge of SAP ERP (ICON) and other IT systems Desirable Skills/Experience: - Experience within manufacturing, packaging and working within a GMP controlled environment - Exposure to Lean ways of working and methodologies At AstraZeneca, we are driven by constant challenges that stimulate us intellectually and provide opportunities more »
of work Support a culture that enhances awareness to reduce accidents and near misses Carry out duties ensuring the site achieves and maintains required GMP standards Ownership of Site services plant including Boilers, Steam & condensate; Effluent plant and water services, Fire alarms and testing; Compressed air services; Hydraulics; Refrigeration & HVAC more »
Northwich, Cheshire, North West, United Kingdom Hybrid / WFH Options
Dechra
s products. Provide US and European regulatory intelligence, train Subject Matter Experts and provide internal consultancy for quality compliance implementation and FDA/EU GMP/GDP remediation projects in the Dechra Internal Manufacturing network. Frequent global travel is required with this role, and you will need to travel to … manufacturing network (as required) across the product's registered lifecycle in compliance with all applicable ISO, ICH, FDA, EU, and national regulatory requirements for GMP/GDP. Lead GMP/GDP audits for Dechra DPMS based on specific expertise, criticality, and complexity. Periodically assess the liability, regulatory and/or … networks are all being adequately monitored. Recruit, lead, train and develop, as required, the team of quality and compliance experts (specialised in auditing different GMP/GDP areas) across the business, to keep the business abreast of ongoing developments through benchmarking activities, whilst proactively identifying and addressing any gaps relating more »
Alderley Edge, Cheshire, North West, United Kingdom
Russell Taylor Group Ltd
product investigations Coordinate and resolve immediate/urgent customer complaints, ensuring prompt responses/resolution Participate in the internal audit programme to ensure continued GMP compliance of all site activities Utilise scientific resources in order to work on improving quality of products and services To maintain personal training folder in … Controls CAPAs Deviations Complaints Recalls OOS/OOT The Person: Will have a Degree in a relevant- Scientific discipline Will have good knowledge of GMP & experience in steriles is essential! Experience in CAPA, Deviations, OOS, OOT, Internal auditing (preferred), Customer Complaints handling would be very advantageous Strong IT skills (Microsoft more »
a Quality Director to head up a Quality department. The Quality Director will promote and integrate quality into every aspect of the business ensuring GMP compliance and meeting the authority's expectation. The role holder will perform all duties required of a Quality Director, provide leadership to the Quality Teams … the business and provide support to sister company for regulatory inspections and conduct self-inspection program Oversee the Pharmaceutical Management System. Implement the current GMP regulations and industry best practices, where applicable Support and develop the QA team Support/lead manufacturing deviation or testing out-of-specification/out … of-trend investigations Audit the contract manufacturing organisation and laboratory against EU GMP and relevant regulations and guideline Qualifications and Skills: Qualified Person (QP) Knowledge and experience in manufacturing and testing of oral dosage forms and topical products Experience in releasing medicinal products in a fast-paced environment Experience in more »
reference for complex containment solutions for pharmaceutical chemical and biologics manufacturing projects. You'll be responsible for the selection, design, and startup of effective GMP containment technology and its performance, delivered to cost and schedule targets. You will have a direct impact selecting and integrating future containment technologies to enable … quality requirements. Supporting procurement’s strategic supplier management efforts, including establishing qualified suppliers and driving bid evaluations. Providing construction phase technical audits and leading GMP equipment testing and FAT’s, including authorization to release equipment from supplier to AZ site. Providing technical support to GMP equipment commissioning and validation, including … project delivery from business case development through project execution, including the specification, procurement, installation, start up and commissioning of containment equipment in a licensed GMP commercial plant. Knowledge of risk assessment methodology and the effectiveness of maintenance and cleaning methods, and how they may mitigate potential exposure. Ability to collaborate more »
and KPIs. Raise any training issues with HR or the Training Manager. Maintain a clean as you go area and demonstrate goodmanufacturingpractice (GMP). Support the need for change and actively get involved in continually looking for ways to improve performance. Takes part in Continuous Improvement activities and more »
