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Lead Quality Assurance Specialist

3 months ago

Romford, Greater London, United Kingdom Ethypharm Full time

Ethypharm stands as a prominent mid-sized global pharmaceutical entity dedicated to the production and provision of vital medications, emphasizing hospital care, central nervous system treatments (including severe pain and addiction), and internal medicine.

Our mission is to enhance patient outcomes and positively influence society and the environment.

With a workforce of 1,700 professionals engaged in various pharmaceutical operations, 1,400 of whom are involved in industrial functions, Ethypharm operates six manufacturing facilities across France, the UK, Spain, and China, specializing in injectables and complex oral solid dosage forms.

Our global footprint spans 68 countries, with direct marketing efforts in Europe and China, alongside strategic alliances in the EMEA, NA, LATAM, and APAC regions.

Ethypharm collaborates closely with regulatory bodies and healthcare practitioners to ensure the appropriate use of its medications and to guarantee patient access to these essential products.

To learn more about Ethypharm, please visit our website and connect with us on LinkedIn.

We are currently seeking a seasoned Lead Quality Assurance Specialist who will report directly to the Quality Assurance Operations Manager.

Role Overview

The Lead Quality Assurance Specialist is responsible for executing daily tasks associated with the Quality Assurance function, ensuring the seamless release of products and compliance with cGMP standards and site Quality Systems, while also providing guidance and mentorship to small teams of QA Officers.

Key Responsibilities

  • Ensure that all site activities adhere to cGMP and the established Quality System across all departments, including participation in both internal and external audit programs.
  • Oversee production operations to consistently uphold high standards of cGMP and general cleanliness.
  • Conduct batch reviews prior to formal approval by the Qualified Person (QP) for both licensed and unlicensed products, ensuring compliance with company and regulatory standards.
  • Manage non-conformances identified by the business, ensuring they are reported, investigated, and that corrective actions are implemented within agreed timelines.
  • Contribute as a Quality Assurance Subject Matter Expert (QA SME) to cross-functional projects and investigations, collaborating with multidisciplinary teams as required.
  • Lead and supervise members of the QA department, stepping in for the QA Team Leader when necessary.
  • Provide performance metrics for individual sections and team outcomes.
  • Collaborate with line management to investigate batch rejections and identify preventive measures.
  • Seek opportunities to minimize batch losses and actively participate in reviews aimed at enhancing effectiveness and efficiency.

Candidate Profile

We are looking for a Lead Quality Assurance Specialist to support our facility expansion and new product launches across various dosage forms. Ethypharm promotes a progressive approach to Quality, led by a blend of experienced and newly recruited experts. The ideal candidate will embody a culture of continuous improvement, showcasing a history of change management, proactive engagement, and strategic thinking grounded in a robust quality ethos. Success in this role requires a passion for problem-solving, initiative, and a desire to contribute to growth and enhancement through teamwork and collaboration.

Qualifications and Experience

  • A degree in a life science or an equivalent qualification.
  • 3-5 years of experience in the pharmaceutical sector, with 2-3 years specifically in Quality Assurance, including batch review experience.
  • Familiarity with pharmaceutical manufacturing and quality systems.
  • Understanding of GMP and Data Integrity principles relevant to the pharmaceutical industry.
  • Proficiency in Microsoft Office applications.
  • Experience in root cause analysis investigations is preferred.
  • Knowledge and management of non-conformances is advantageous.

What We Offer

  • A competitive salary.
  • 25 days of holiday, increasing to 30 with length of service, plus bank holidays.
  • Holiday Buy/Sell option, allowing the purchase or sale of up to an additional 5 days of holiday.
  • 5% discretionary bonus scheme, subject to policy eligibility.
  • Bravo Benefits Platform, offering a range of discounts for well-being and lifestyle.
  • Salary Sacrifice scheme for electric vehicles, subject to policy eligibility.
  • Private healthcare coverage for you and your family (if applicable), along with an additional Medicash health cash plan.
  • Pension scheme.

At Ethypharm, we value diversity in the workplace and are committed to providing equal opportunities for all. We are open to discussing flexible working arrangements that align with our business needs. For more information about Ethypharm, please visit our website.