Job Reference: J5630840
Updated On: 29/05/2019
Status: Open to Applications
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Role OverviewWe are currently looking for a Senior Validation Manager to join a leading multinational Pharmaceutical company with multi site responsibilities based out of their global headquarters in Northern Ireland. As the Senior Validation Manager you will be responsible for developing and maintaining the companies validation strategy for their drug product development services and oversee its implementation across each site
Key Duties and ResponsibilitiesYour duties as the Senior Validation Manager will be varied however the key duties and responsibilities are as follows:
1. Develop global standards on validation and support sites to implement and comply, as well as the line management of a number of Technical Quality teams accountable for all aspects of the validation program including facility, equipment, utilities (FEU), process, cleaning, shipping and computerised systems.
2. You will deliver qualification / validation in accordance with industry expectations and commensurate to the risk of the system / operation, whilst liaising directly with clients to develop the validation strategy for the introduction of new commercial products.
3. As the Senior Validation Manager you will participate as required in regulatory inspections, customer and internal audits. You will act as a quality SME during investigation of deviations / complaints, change requests etc, which require input of a technical nature. You will also make proposals and implement actions as part of continuous improvement
4. You will take the lead on attracting, developing, and retaining a high performing team to meet the current and evolving needs of the business. This should be achieved by effective selection, training and development, coaching and performance management.
Role RequirementsTo be successful in your application to this exciting opportunity as the Senior Validation Manager we are looking to identify the following on your profile and past history:
1. Relevant degree in a scientific discipline (i.e Chemistry, Chemical Engineering etc) or qualified via experience with extensive experience working within an established Pharmaceutical Quality System with proven oversight for validation strategies.
2. Proven industry experience leading a quality / validation function preferably, but not limited to, working in an environment supporting the manufacture and control of a range of solid oral dosage products
3. A working knowledge and practical experience with the regulatory requirements governing quality and Qualification / Validation in the pharmaceutical industry, as well as pharmaceutical technologies and processes.
Key Words: Validation Director / Quality Manager / Validation Lead / Quality Director / Head of Validation / GMP / Pharmaceutical / Pharmaceutical Processes / MHRA / FDA / GMP / QMS Management
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