Role Overview
This position assists in site quality compliance, inspection readiness activities and the sites quality management system (QMS) to ensure compliance with the applicable regulations and customers. The role supports the day-to-day activities and maintenance of the Quality Compliance group in the support of the site’s Operations (manufacture, testing, shipment, etc.). The person filling this role will be responsible for assisting in the completion of compliance documentation, engineering and validation support, customer and supplier management and daily PQS and eQMS oversight.
Core Responsibilities
* Build and strengthen Veranova’s quality culture and compliance through functional excellence and involvement in organisational forums.
* Collect, review, and report the monthly quality key performance indicators (KPIs) at site level. Ensure that action plans are in place and on track for all items at or above the action limit partnering with the applicable functions. Provide KPI visibility across site.
* Support and participate in internal, customer and supplier audits
* Ensure timely and effective communication with clients on Quality Audit Reponses and CAPA, addressing any concerns and providing updates on ongoing quality issues or regulatory matters.
* Provide support where required to GMP manufacturing activities, batch record review, and batch release.
* Responsible for preparation and/or and review of Quality Agreements with suppliers and customers, liaising with the Quality Operations team as needed and in alignment with Veranova requirements
* Participate in the review and approve controlled documents, including deviation, change control, CAPA reports, batch records, SOPs, and product and material specifications.
Qualifications
* Minimum 3 years of quality assurance experience
* Experience working within Quality Compliance and Supplier Management
* Demonstrated proficiency and knowledge of cGMP, ICH, and other US and worldwide regulatory requirements
* Working knowledge of US & EU GMP, ICH Q7 and Part 11 compliance
* Excellent analytical, written and verbal communication and presentation 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.
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.
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