Lead Quality Assurance Specialist

3 weeks ago


Berwick, Northumberland, United Kingdom Sterling Pharma Solutions Full time

Overview of the Lead Quality Assurance Specialist Position

In the role of Lead Quality Assurance Specialist, you will collaborate closely with the Senior Operational Quality Manager. This position is primarily site-based, operating on a standard weekday schedule.

As a vital member of our Quality team, your key responsibility will be to execute batch approval processes for a designated range of products, alongside all quality assurance functions such as reviews, approvals, and audits pertinent to those products and specific operational sectors. You will oversee quality management systems within your areas of expertise, ensuring compliance with current Good Manufacturing Practices (cGMP) and regulatory guidelines.

About Sterling Pharma Solutions

Sterling Pharma Solutions is a rapidly expanding global Contract Development and Manufacturing Organization (CDMO) with over five decades of expertise in the development and production of Active Pharmaceutical Ingredients (APIs). We are recognized as a reliable partner for some of the most pioneering biotech firms and leading pharmaceutical organizations, particularly noted for our proficiency in handling complex and hazardous chemical processes.

Our dynamic workforce consists of more than 1300 dedicated professionals across the UK, US, and Europe, all committed to assisting our clients in the journey of bringing innovative medicines to market, ultimately enhancing and saving patient lives. We provide comprehensive support throughout the entire product lifecycle, from initial development stages to large-scale commercial production, fostering a culture of scientific excellence and unparalleled service.

Your Key Responsibilities

  • Conducting timely sentencing of all controlled intermediates and finished products in accordance with established protocols, which include production and analytical evaluations, as well as deviation and change assessments.
  • Overseeing quality assurance approvals for Process Record Sheets (PRSs), modifications (process, analytical, and engineering procedures) related to specific products, ensuring adherence to relevant product registrations and customer notification protocols.
  • Executing quality assurance evaluations of all 'Decision Paths', non-conformances, and deviations (including calibration issues).
  • Reviewing all cGMP cleanout procedures to confirm that manufacturing does not commence until a satisfactory cleanout is completed.
  • Approving all documentation, including master Process Record Sheets (PRSs), monographs, and procedural documents.
  • Utilizing the Master Control electronic quality management system for document and deviation approvals, as well as SAP for batch management and release.
  • Adhering to all environmental, health, and safety regulations.
  • Embodying our core values: Be Transparent, Be Willing, Be Reliable, and Be Caring.

Qualifications for the Role

  • Proven experience in quality compliance management.
  • Preferably holding a degree or equivalent qualification in a scientific discipline.
  • Strong problem-solving abilities, lateral thinking, and excellent written and verbal communication skills, along with the capacity to collaborate effectively within a multidisciplinary team.
  • Essential knowledge of cGMP, MHRA, and other regulatory standards.
  • Alignment with our core values: Be Transparent, Be Willing, Be Reliable, and Be Caring.

Why Join Us?

Our unique collaborative and empowering culture distinguishes us as a business, built upon our four core values: Be Transparent, Be Reliable, Be Willing, and Be Caring. We implement various initiatives across our locations to promote health, well-being, and work-life balance, while also supporting causes and charities that resonate with our employees. We encourage community involvement and organize social events through our global social committees to foster team spirit and recognize our team's contributions.

At Sterling, we uphold mutual trust and respect, celebrating the diversity of our workforce, which mirrors the richness of life itself. This diversity enhances our workplace, driving innovation and collaboration.

We provide a competitive compensation and benefits package, including bonuses, pension schemes, private healthcare, employee engagement initiatives, cycle-to-work schemes, death-in-service coverage, on-site health and wellness support, 24/7 employee assistance programs, referral incentives, and opportunities for training and career advancement.

Be caring. Be transparent. Be willing. Be reliable.

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