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

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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

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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)

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​​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.