Onyx is now licensed to manufacture commercial API from our UK facility

Qualified Person (QP)

Purpose of Job:
To perform the legal and routine duties of a QP with respect to the review, approval and certification of licensed products of Ipca Laboratories UK Limited (the company) as defined Directive 2001/83/EC and described in Annex 16 of the EU Guide to GMP

  • Act as GMP Subject Matter Expert (SME) to facilitate compliance with the company’s Quality Management system
  • Lead and manage the QP/ Release group, including contracted QPs, Trainee QPs, and other releasing officers
  • Ensure systems are identified and in place to maintain compliance with current established GxP standards.
  • Support senior QA leadership through QP decision making to drive continuous improvement and compliance.

Full-time role, will be based at our Sunderland location preferably

Major Activities and Responsibilities

  • Ensure batches imported are manufactured and tested to GMP and in line with the MA grant
  • Review completed batch records and complete batch disposition
  • Develop and own the batch release process
  • Review and approval of non-conformance including deviations, customer complaints, out of specification investigations, laboratory investigations
  • Provide QA oversight, technical QA expertise and leadership across all aspects of GXP Operations from Manufacturing, Tech Transfer through Warehouse activities, Quality Control, Supply Chain and Operations support
  • Identify, communicate, and escalate quality and compliance risks. Provide direction for and participate in timely resolution, acting always with an appropriate sense of urgency
  • Attend and participate in the Quality Management Review meetings
  • Ensure that complaints, deviations, and any significant quality incidents are thoroughly reviewed and closed out in a timely manner
  • Ensure changes are appropriately managed
  • Approval of procedures and policies
  • Undertake continuous improvement of business quality systems
  • Advise and participate in projects from a quality assurance perspective
  • Keep up to date with regulatory changes and developments, aiding the transition into company SOPs and processes
  • Assist with regulatory inspections providing SME support. Assist in the remediation of regulatory findings and closure of deficiencies
  • Ensuring audits are carried out to a defined schedule for Third Party manufacturers suppliers, testing laboratories, transport companies and any other service providers to the company. To independently verify the audit reports and program compliance, escalate any adverse trends or major non-conformances reported and make recommendations on appropriate corrective action in support of the approval / rejection of suppliers or products
  • Support self-inspection process, providing coaching to self-inspection auditors and review of the outcomes of audits
  • Strong interpersonal skills must have the ability to establish and maintain effective working relationships with internal and external peers and stakeholders
  • Update and inform the management team on time to time basis about its compliant status, from a GXP and regulatory perspective
  • Support the internal development of other quality team members, through training and mentoring

Qualifications

  • A minimum of a first degree in Pharmacy, Chemistry or a Life Science or significant experience (e.g.>10 years) in a regulated pharmaceutical function
  • Eligible to act as a Qualified Person in accordance with Human Medicine Regulation 2012 / European Directives 2001/83/EC as amended and meet all the relevant qualification requirements stipulated
  • A minimum of 5 years’ experience in a pharmaceutical Quality environment, with experience as a certifying QP preferable

Experience

  • Operational experience within a Pharmaceutical products importation and laboratory setting is desirable
  • Experience working with oral solid dosage forms, including capsules and tablet formulations and / or non-sterile liquids and suspension
  • Excellent communication skills both verbal and written are required in this role and people management skills would be beneficial
  • Proven track record in the management and hands on hosting of Regulatory Inspections by international regulatory bodies. Involvement in internal, customer, regulatory inspections/audits as required

Applicants must be able to work permanently in the UK. Email – Nathan.lane@onyxipca.com


Apply for the position of Qualified Person (QP)