Quality Lead
2 months ago
Location: Slough, Berkshire
Type: Permanent
Posted: 21 Mar 2024
**Office-based**:
**Company Overview**:
Our client is an international biopharmaceutical company, who are passionate about promoting health and wellbeing for all by developing a portfolio of innovative, next-generation products.
- Knowledgeable and supportive management team.
- Patient-centric and increased treatment accessibility focus.
- Competitive starting salary and extensive benefits package.
**Job Overview**:
- Implementation and maintenance of the Quality Management System (QMS), including SOP generation and review, ensuring compliance with GDP regulations
- Provide the Leadership Team with regular reports regarding the Company’s Quality KPIs, including CAPA plan
- Deviation and change control management, training, outsourced activities, and self-inspections
- Conduct supplier checks, approvals and audits, ensuring adherence to the relevant GDP/GMP standards.
- Ensuring the correct GDP training programmes are rolled out to both new starters as well as existing employees within the business.
- Line management of QA/RA Associate with defined delegation of QA and RA responsibilities, keeping appropriate records of these delegated duties
**To be successful**:
- A bachelor’s degree in pharmacy, chemistry, or other related field, with a strong understanding of GMP and GDP principles
- Minimum of three years’ experience as a Responsible Person in a pharmaceutical environment
- Previously named as an RP/RPi on a WDA licence.
- Accomplished and experience in conducting internal audits and hosting regulatory inspections
- Excellent knowledge of EU & UK GDP, GMP, and regulatory requirements for pharmaceutical products
- Excellent communication, organisational and leadership skills
**How to apply**:
Star People is the strategic recruitment and outsourced partner for pharma, medtech and biotech.
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