Qualified Person |£80000 - £90000 per annum
Pharma & Science
Permanent
London

Qualified Person

Additional Information

Location: East London

Salary: Competitive + Bonus + Benefits

Job Type: Permanent

Job purpose

Reporting to the QA Operations Manager, the QP is responsible for the final release of a batch of pharmaceutical finished products, ensuring they meet the required quality standards to ensure patient and company safety.

Main Responsibilities and Duties

Working in accordance with the duties of a Qualified Person as defined in Article 51 of 2001/83/EC, key responsibilities include:

  • Timely release of products, ensuring that the product is fit for its intended use, complies with the requirements of the relevant Manufacturing License, the Marketing Authorisation (MA) and does not place patients at risk due to inadequate safety, quality and efficacy
  • Ensure that all activities within the area are undertaken to established standards of cGMP
  • Ensure QP input to Streams through involvement with training, deviation investigation & reporting and overall coaching/mentoring of stream leadership in quality matters
  • To assist in the investigation of Incidents, Deviations and Customer Complaints including Root Cause Analysis
  • Work with other Stream members in developing reports on quality incidents e.g. deviations, batch failures, etc. to support the action taken and reflect the investigation and risk assessments undertaken
  • Represent an area where required at Site Quality Review Group
  • To assist in the implementation of CAPA’s and Change Controls
  • Work with all Operations & Quality management to agree overall quality improvements and act as the driver for these improvements
  • Provide Quality Assurance support on projects when required
  • To review and authorise company documents e.g. Artwork, Batch Records, and Specifications etc. On behalf of the QA function
  • Constantly drive to deliver high standards of GMP and general housekeeping
  • Foster and actively support a culture of continuous improvement
  • Lead internal/external quality audits. Ensure implementation of resulting improvement recommendations or compliance gaps, in accordance with the site Quality Plan process
  • Ensure that all Deviations and Change Controls are reported and investigated with corrective actions completed to agreed timescales
  • Ensure that losses due to reject batches are reduce to a minimum through root cause analysis of issues and elimination of those causes
  • To assist in the company supplier audit program
  • To assist in the company internal audit program
  • Ensure full compliance with Annex 16 EUGMP
  • Compliance with relevant section of Directive 2017/1572

Experience and Qualifications

Experience

  • Prior experience in compliance management, with comprehensive knowledge of GMP requirements, quality systems and pharmaceutical manufacturing, packing and testing technologies
  • Previous experience of MHRA inspections
  • A high level of technical process understanding across a range of manufacturing areas, including sterile and aseptic manufacturing
  • Previous experience of quality system auditing (internal and external)

Qualification

  • Degree in a science related subject (e.g. chemistry, microbiology or pharmacy), or equivalent
  • Eligible for nomination as a Qualified Person on the site manufacturers licence
  • Member of the RCS, RSC or IOB

Knowledge

  • Good level of pharmaceutical manufacturing and distribution
  • Knowledge of EU Regulatory guidelines and product licensing processes
  • A good knowledge of quality systems (compliance, CAPA, continuous improvement etc).

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