Validation Coordinator at Veranova L P

City of Edinburgh, Scotland, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

01 Jul, 26

Salary

0.0

Posted On

02 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Validation, Process Technology, Analytical Skills, Project Planning, Risk Assessment, Interpersonal Skills, Leadership Skills, Compliance, Document Review, Data Collation, Protocol Writing, Equipment Qualification, Cleaning Validation, Manufacturing, Development, Quality Assurance

Industry

Pharmaceutical Manufacturing

Description

Discover Veranova: At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented and diverse workforce in our industry. Our commitment to uncompromising focus on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference. Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation. Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients. Role Overview: To co-ordinate qualification activities and co-ordination of validation activities related to process and cleaning validation. To work to an agreed validation plan. To assist in the document review of equipment qualification. Core Responsibilities: * Liaise with all departments that are necessary to the delivery of the job purpose. Close liaison is required between Manufacturing, Development and Quality Departments. * In consultation with Production, Development, Compliance and Quality representatives, to formulate a strategy for the individual validation studies, based on previous validation experiences, company policy, guidelines and procedures and the needs of the particular product * Prepare Validation Master Plans as required * Co-ordinate the activities of the validation plan aligned with production requirements * Collate data from historical reports and pre-validation manufacture to enable the writing of qualification and validation protocols * Write qualification and validation protocols including periodic reviews, and reports for processes and cleaning validation * Assist in qualification of production equipment and hardware/software with authority to approve non-critical deviations and give interim protocol approval. This can also include execution activities * To perform risk assessments related to all validation activities including the evaluation of change controls Qualifications: * A degree in a Chemistry related subject * Experience in implementing validation policies and procedures * Experience in process technology * Process development, analytical, technology transfer and manufacturing functions * To be able to plan effectively small projects and compliance initiatives * The job holder will require good judgement, resilience, drive to succeed, political awareness, interpersonal and leadership skills Our Commitment: * Inclusive Culture: At Veranova an inclusive culture is integral to our values. We are committed to ensuring that everyone can bring their full self to work and thrive in their career. * Financial Wellness: The company provides an industry-leading compensation package, and this position is eligible for an annual performance bonus in accordance with the terms of the applicable bonus plan. You will also receive excellent pension contributions with the option of making contributions via salary sacrifice and access to discounts from major online and high street stores. * Health & Wellbeing: As well as being entitled to 25 days’ annual leave plus recognised Scottish public holidays, our colleagues are also eligible to participate in benefits such as our Health Shield Cash Plan, Cycle2Work Scheme, life insurance, income protection, and GP Anytime. * Professional Development: Opportunities for continuous growth and development through resources such as LinkedIn Learning, functional career pathways, and individual Personal Development Plans to map out your future with us. Additional Information: Under UK legislation, we are required to ensure that all employees have the legal right to work in the UK, both at the time of offer and throughout their employment. Please note that we are not able to provide sponsorship for this role, so applicants must have the necessary right to work in place independently. Agency and Search Firm Representatives: Veranova will not accept unsolicited applications/CVs from agencies and/or search firms for this job posting. Veranova is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, marriage or civil partnership, pregnancy or maternity, religion or belief. All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice [https://veranova.com/privacy-policy/].

Responsibilities

The Validation Coordinator will coordinate qualification and validation activities related to process and cleaning validation, working closely with various departments. They will prepare validation plans, write protocols, and assist in the qualification of production equipment.