Quality Assurance Specialist

Posted 22 February 2024
Salary Negotiable
Job type Full Time
Discipline Large Molecule
Contact NameHuseyin Pulat

Job description

Mantell Associates is partnered with an innovative organisation searching for a Quality Assurance Specialist to join their growing team.

Quality Assurance Specialist - Responsibilities:

  • Assist QA manufacturing activities to ensure compliance with current GMPs

  • Manage and maintain QA records (i.e., logbooks, equipment records, specifications, procedures)

  • Manage Change Control Order system

  • Responsible for Record Retention activities associated with all GMP documentation maintained by Q.A.

  • Identifies and initiates quality improvements in systems and procedures

  • Provides incoming and in-process support activities as required

  • Responsible for ongoing review, design, and implementation of cGMP standards

  • Review all aspects of pharmaceutical manufacturing and identify any deficiencies

  • Create/maintain/organize manufacturing staff GMP training records

  • Supervise and maintain the deviation, investigation change control, SOP validation and batch record review systems

  • Ensure the proper storage of controlled documentation (archives, back-ups)

  • Review, approve and maintain certifications related to products, manufacturing supplies, and calibration records

  • Supervise the schedule for the calibration of manufacturing equipment

  • This includes scheduling and verifying the performance of the calibration

  • Generate and prepare client batch record package, review batch record for completeness and accuracy

  • Develop, modify, and create new format of batch records depending upon products (clients) needs

  • Review and approve completed job folder generated by receiving department

  • Review technical information provided by client for formulation process and components capability which will be used for the preparation of the batch record

  • Verify the proper storage condition for received material such as API (active pharmaceutical ingredient) and any other excipients

  • Responsible for the release of all raw material and manufacturing supplies

  • Issue and assign the proper tests required for in-process and final process testing to the analytical laboratory

  • Audit the manufacturing supplies (critical components) retention against record, completeness, and accuracy

  • Responsible for the release of manufacturing area clearance for the initiation of new filling projects

  • Supervise shipping of final products to clients

  • Prepare batch record for various media fills

  • Responsible for the accountability of the number of vials or syringes manufactured, shipped, or retained

  • Inspect final product vials for foreign particulates

  • Responsible for the custody of final product vials and their proper storage

Quality Assurance Specialist - Requirements:

  • Minimum of Bachelor's degree in the Life Science industry (or related)

  • Experience in a Quality Assurance position within a highly regulated industry

  • Relevant GMP experience in a Pharma/Biotech company, working within quality system and regulated GMP environment

  • Strong understanding of quality control standards and testing techniques

  • Knowledge of cGMP/ICH/FDA/EU regulations and guidance

  • Proficient in using Microsoft applications (Microsoft Word, Microsoft Excel, Microsoft PowerPoint)

​​Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.