Regulatory Compliance Officer

3 weeks ago

Durham, Durham, United Kingdom Real Staffing Group Full time
Job Overview

Our client, a distinguished pharmaceutical organization, is committed to innovative approaches that enhance global access to essential and affordable medications.

With a presence in over 85 countries, they are currently seeking a Regulatory Compliance Officer to become a vital part of the Quality Assurance team. This role focuses on the efficient release of solid oral dosage products, ensuring that all batches are released promptly and in accordance with the marketing authorisation, as well as adhering to company and industry compliance standards.

Key Responsibilities:

  • Conduct thorough checks of site Good Manufacturing and Distribution Practices (GMDP), including production conditions and manufacturing records. Review deviations and planned change authorisations, and perform quality checks such as sampling, inspections, and audits. Investigate complaints to ensure effective corrective and preventative actions (CAPAs) are implemented.
  • Maintain the Pharmaceutical Quality System (PQS) and ensure all departmental documentation is up-to-date and compliant, including standard operating procedures (SOPs), technical agreements, and management reports to monitor departmental performance and identify trends.
  • Collaborate with the broader business, represent the organization during inspections, participate in regular Quality team meetings, and build strong working relationships with Quality colleagues across the network.
  • Contribute to the planning of new product launches, promote a Quality-oriented culture across all departments, and assist in establishing best practice quality processes for the site. This may involve monitoring departmental output and providing training or mentorship to junior staff as needed.

Required Skills:

  • Must be eligible to serve as a certified Qualified Person, with practical experience in a UK pharmaceutical environment, certifying products for market.
  • In-depth knowledge of relevant EU legislation, particularly regarding Good Manufacturing Practice (GMP), with experience in a dynamic, high-volume setting.
  • Experience with certifying multiple dosage forms is advantageous, with a preference for solid dose and sterile products.
  • Experience with product transfers and hosting MHRA GMDP inspections is beneficial but not essential.
  • A degree-level qualification in a life science discipline is required.

Specialist Staffing Group is an equal opportunity employer. All qualified candidates will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

For more information about Real Staffing Group, please visit our website.

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