Job Reference: J5631641
Updated On: 05/06/2019
Status: Now Interviewing
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Role OverviewWe are currently looking for a Head of Quality / QA Manager to join a leading pharmaceutical company based in the Hertfordshire area. As the Head of Quality, you will be responsible for managing the QMS, driving change and managing relationships with the MHRA and other regulatory bodies.
Key Duties and ResponsibilitiesYour duties as the Head of Quality will be varied. However, the key duties and responsibilities are as follows:
1. You will be responsible for managing all aspects of the Quality function, including managing a team across QA and QC and for the managing of the QMS to ensure compliance with regulatory requirements. This will involve driving change and implementing continuous improvement and lean processes to ensure the business is operating efficiently.
2. As the Head of Quality, you will ensure the quality, safety and efficacy of released products across API and excipients, and drive the robustness of packaging and product manufacture.
3. You will be responsible for ensuring audit readiness and compliance to regulatory requirements across site, which will see you hosting regulatory inspections and customer audits to ensure products and processes comply with standards and customer quality technical agreements.
4. As the Head of Quality, you will oversee a number of activities across the business, including supplier audits, PQR, validation, QC testing, stability, warehousing, licence product maintenance and customer complaints.
Role RequirementsTo be successful in your application to this exciting opportunity as the Head of Quality, we are looking to identify the following on your profile and past history:
1. Relevant Life Sciences degree or extensive relevant pharmaceutical experience.
2. Proven industry experience in audit readiness, hosting regulatory and customer audits, external supplier auditing, people management, and management and improvement of QMS.
3. A working knowledge and practical experience with cGMP requirements, validation and qualification.
Key Words: QA / Quality Assurance / GMP / cGMP / QMS / Quality Management System / People Management / Compliance / Drive Change / Continuous Improvement / Lean / API / Product Release / Audit Readiness / MHRA / Regulatory Inspection / Customer Audit / Supplier Audit / QTA / Quality Technical Agreement / PQR / Product Quality / Validation / QC Testing / Stability / Warehouse / Product Licence / Customer Complaints
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