Senior Q&V Specialist

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Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

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Job Title

Senior Q&V Specialist

The role of the Senior Q&V Qualification and Validation Specialist is to ensure governance and compliance of Qualification and Validation (Q&V) and Periodic Review activities at Piramal Grangemouth. The position holder will have responsibility to coordinate, maintain and promote Q&V compliance, leading and supporting continuous improvement of related quality and operational systems.

The role will support and ensure that the site and related functions are in compliance with GxP regulations and applicable quality guidelines, including, but not limited to UK/EU/US GMP/GDP, ICH, ISPE and other region specific guidance. The individual will have ownership for key Q&V quality system elements and will support and execute site quality and compliance improvements, working closely with relevant stakeholders on site.

Essential Qualifications

The holder will normally be expected to be qualified in a technical or scientific area which is relevant to the role. This may be through a formal educational / qualification route or via relevant experience and training obtained through practical application. It may also be a combination of both.

Essential Experience

Technical knowledge of qualification and validation systems for which the holder has responsibility.

Relevant computer system skills

Communication skills – written (technical writing) and verbal

Presentation/ training skills

Planning and prioritising

Client audit & Regulatory Agency Inspection experience

Teamwork

Key Roles/Responsibilities

• Provision of planning, support and guidance for validation projects. This includes:
• Ensuring continuous improvement of validation policies, procedures, templates and working practices.
• Oversight of project plans and milestones in conjunction with project teams in order to meet compliance and customer needs.
• Coordination, resource management and facilitation of validation projects.
• Provision of validation expertise, advice and guidance to the site, Q&V team and 3rd parties to ensure compliance with site policy and procedures.
• Establish validation documentation in conjunction with project teams and in compliance with relevant SOPs and good practice.
• Facilitation of the review and approval of validation documents.
• Practical support during protocol execution and reporting where required and appropriate.
• Oversight, metric reporting and provision of practical support to Periodic Review activities.
• Ensure management of the SVMP Inventory and SVMP Schedule with information provided by validation practitioners.
• Generation of training packages and delivery of training on validation related topics.

Maintain and develop knowledge of current regulatory expectations and industry best practices with respect to validation.

Competencies

• Attention to detail
• Thoroughness
• Planning and Prioritisation
• Good communication skills – written and verbal
• Problem solving