QA Specialist

A leading biopharmaceutical company is currently recruiting an QA - Specialist. This organisation is a global leader and specialist in sourcing, distribution, and management of comparator drugs and other pharmaceutical products and supplies for clinical trials, including biosimilar trials and research. This is an exciting opportunity to join this company in their office in Leicester.

Job Responsibilities:

• Logging customer complaints, assisting with investigations where required, liaising with other departments to ensure timelines are met. Maintaining logs.
• Raising and logging deviations, assisting with investigations to establish root cause, liaising with other departments to ensure timelines are met. Assessing trends. Maintaining logs.
• Raising and logging CAPA and change controls, liaising with other departments to ensure timelines are met. Assessing trends. Maintaining logs.
• Initiating the standard review of SOPs (every 2 years).
• Maintaining GMDP related indexes and files.
• Assisting the QA Manager to implement the annual QA plan and Vendor plans.
• Scheduling and preparing agenda and taking minutes of Quality Management Review Meetings.
• Preparing data in PowerPoint presentations for review.
• Maintaining all training files and circulating SOPs for training in line with matrix.
• Updating records.

• Completing the review and approval process for vendors and subcontractors, including annual re-checks and annual risk evaluation, ensuring verifications are up to date prior to any purchase of product.
• Preparing supplier approval/re-approval documentation.
• Updating approved suppliers list.
• Carrying out customer/delivery site GDP bona fide checks and annual re-checks.
• Updating verified customers list.
• Managing technical agreements with customers and suppliers and initiating review as required.
• Maintaining the calibration schedule and arranging calibration activity in line with schedule.

• Liaising with operations as required.

• Inspecting and releasing GMP starting materials.
• Issuing printed packaging material for secondary packaging/relabeling activity.
• GMP batch record reviews prior to QP releases.
• Carrying out QC in-process checks during GMP secondary packaging / relabeling activity.
• QC outgoing shipments (second check) where required.
• Providing back up support to GDP Logistics Administrator, carrying out the appropriate pre-activity checks for all sales and purchases.

• Checking on goods received documentation, including the review of temperature readings.
• Performing risk assessment as appropriate for transportation.
• Liaising with contract storage sites as required.
• Updating business system as appropriate with stock receipts and despatches, including notes and updates for both purchases and sales.
• Ensuring stock location is appropriate and correctly recorded.
• Ensuring any import of unlicensed product into the UK is correctly processed and the relevant import licences applied for and received prior to receipt of the product.

• Performing any other duties or tasks related to GxP as instructed by the QA Manager / Lead RP.
• Assisting with maintaining the filing of GxP records.
• Proposing improvements as appropriate.
• Maintaining appropriate records for all activities as described in SOPs.

Skills and Requirements:

• Ideally a University degree or equivalent.
• 2 years+ experience in a similar position within a GMP pharmaceutical environment is a requirement.
• GMP experience is highly desirable.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Josh Godden at + 442038540101 or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

#LI-JG1

#Compliance/Quality