Qualified person - contract
SRG are working with a global Pharmaceutical company to help them find a Qualified Person to join their busy team.
This is a great opportunity to join a leading name in the Pharmaceutical industry for a 6 month contract
Undertake QP responsibilities for certification and release of intermediate and finished IMP in compliance with GMP, Manufacturing Authorisation, Clinical Trial Application and regulatory requirements.
Interpretation and communication of GMP regulatory requirements to staff and customers including Investigational Medicinal product specific GMPs and their interface with GCPs.
Review and approval of non-conformance including deviations, customer complaints, out of specification investigations.
Review and approval of control documents e.g. SOPs, quality agreements, Packaging records. Involvement in internal, customer, regulatory inspections/audits as required.
Must be eligible to act as a QP for Investigational Medicinal Products, as defined by The Medicines for Human Use (Clinical Trials) Regulations 2004 under permanent provisions. Experience working with oral solid dosage forms, including capsules and tablet formulations and /or inhalation products including non-sterile liquids and suspensions.
Strong decision-making skills based on GMP requirements.
Able to work calmly under pressure in an environment where a range of issues will pull upon your time and where there can be conflicting priorities.
Experience of sterile products
Knowledge of product development particularly IMP specific GMPs.
Experience of packaging activities relating to finished clinical trial packs of Investigational Medicinal Products.
your application has been submitted