Quality Assurance Specialist

Quality Assurance Specialist (Validation)

Location: Loughborough

Hours: 37.5 Mon-Fri

Salary: Competitive

Business Unit Pharma Services (Charnwood)

Open To: Internal & External Applicants

Ref No.: HRJOB9813

The Role

A typical day for a Quality Assurance Specialist in Almac Pharma Services is far from typical. The role is varied and dynamic. You will play a pivotal role in supporting QA activities with a focus on qualification and validation in line with Almac Pharma Services global standards. Responsibilities include QA oversight of facility, equipment, and utility qualification, as well as approval of various QA documentation like SOPs, Change Controls, Deviations, and CAPAs.

As the post holder, you'll be involved in reviewing and approving validation lifecycle documentation, conducting Data Integrity risk assessments, and acting as a QA Validation Subject Matter Expert for planned and unplanned changes. Keeping up-to-date with regulatory requirements and industry expectations is key, along with providing crucial support for site compliance to ensure quality assurance.

Please see attached job description for further details.

Key Requirements

Applicants must have eligibility to work in the UK OR possess a valid work permit that will allow you to take up full time, permanent employment in the UK

Essential Criteria

· A Level Qualifications (or equivalent) in a Scientific subject and Mathematics

· Significant experience in a QA role within a Pharmaceutical Quality System

· Effective communication skills (both written and oral)

· Proficiency in use of IT applications (Word, Excel, Outlook, Project, PowerPoint etc)

· Excellent attention to detail

· Proven ability to work effectively on own initiative as well as effectively contributing to the team environment

Desirable Criteria

· Masters or Bsc in a scientific subject (or equivalent)

· Previous experience in writing and producing detailed reports

· Direct experience in the manufacture of solid oral dosage products

· Quality Risk Management

· Root Cause Analysis

· Lean six sigma trained

Please see attached job description for further details of criteria.

Apply Now

Apply online and tailor your CV to outline how you meet the role criteria. Please upload your CV in PDF format where possible.

Closing Date

We will no longer be accepting applications after 8pm on Wednesday 06 Nov 2024

RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role by our Talent Acquisition team. Speculative candidate CV’s received or submitted directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.