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Qualified Person

3 months ago

Durham, United Kingdom Real Staffing Full time

Our client is an award-winning pharmaceutical company driven to thinking differently so that more patients around the world have access to the essential and affordable medicines that they need.

They have operations in over 85 countries worldwide.

They are looking for a Qualified Person (QP) to join the Quality Assurance team to support the high-volume batch release function of solid oral dosage format products, ensuring all product batches are released in a timely manner, in-line with the provisions of each product's marketing authorisation, along with company and industry compliance requirements.

Responsibilities:

  • Range from checking site GMDP (including production and distribution conditions and manufacturing records), reviewing deviations and planned change authorisations, verifying and performing quality checks (including sampling, inspections and audits) and investigating any complaints to ensure appropriate corrective and preventative actions (CAPAs) are taken.
  • Ensure the PQS system and all departmental documentation remains current and compliant at all times, including standard operating procedures (SOPs), technical agreements and reports for management to monitor departmental data and identify any performance trends.
  • Support the wider business, represent the company at inspections, attend regular Quality team meetings and establish good working relationships with Quality colleagues across the company network.
  • Contribute to new product launch plans, foster a Quality mindset across all departments and help establish best practice quality processes for the site; this may include monitoring departmental output and engaging in training or mentoring more junior colleagues, as required.

Skills:

  • Eligible to act as a certified Qualified Person (experienced or newly qualified), with practical QP experience in a UK pharmaceutical setting, certifying product to market
  • Knowledge of relevant EU legislation, particularly around good manufacturing practice (GMP), with experience working in a fast-paced, high volume environment
  • Certifying multiple dosage forms would be beneficial, but solid dose and steriles experience would be beneficial
  • Product transfers and hosting MHRA GMDP inspections advantageous but not a deal breaker
  • Degree-level qualification in a life science subject

Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

To find out more about Real, please visit www.realstaffing.com