• MAC

GMP SENIOR QUALITY ASSURANCE ASSOCIATE


Closing date for applications: 30 June 2021

MAC Clinical Research manages clinical trials for the pharmaceutical industry and we are seeking to appoint a GMP Senior Quality Assurance Associate to join our team and make a positive impact in a world-leading CRO.


This role will be based at our Manchester Clinic, with travel to cover other sites as required.


The focus of this role is to support the GMP QC Manager to maintain compliance within the GMP Production Facility.


KEY RESPONSIBILITIES:

  • Evaluate of batch records and completion of QC Checks for IMP release.

  • QC checks of clothing, cleaning materials and other GMP consumables and materials used in the GMP Production Unit, involved in Investigational Medicinal Product (IMP) manufacture.

  • Maintenance and trending of the environmental monitoring data for GMP cleanrooms.

  • Ensure deviations are raised on time and actions arising from Events & CAPAs for the GMP site are followed up to completion.

  • Assist with the completion of root cause analyses, corrective and preventive actions.

  • Assist with the generation, maintenance and review of risk management processes.

  • Assist with the preparation of essential documents required for batch manufacturing and release activities, and to assist with the timely updates of the Product Specification Files before QP review. Quality control and approval / rejection of Production materials

  • Final quality control checks on all IMP manufactured in the Production Unit, before QP release, after an agreed training assessment period.

  • Final quality control checks on all IMP prepared post QP certification in the Production Unit, after an agreed training period.

  • Maintain oversight of the GMP QMS to ensure continuing compliance with SOPs and applicable regulations.

  • Assist with the checking and approving of documentation including Batch Manufacturing Records and Validation documentation before use

  • Assist with the generation of Validation documentation before use.

  • Assist with the hosting of external audits or inspections from clients or regulators.


KEY REQUIREMENTS:

  • 3 years GMP Production experience

  • Background in Microbiology, Chemistry or similar life science

  • Good interpersonal skills

  • Strong skills with Microsoft Office (eg Word, Excel)

  • Able to write clear and concise reports

  • Good attention to detail and excellent organisational ability

  • Sufficient initiative to be able to work alone and with a team

  • Some experience in a clinical environment would be useful


BENEFITS:

  • Competitive salary in keeping with pharmaceutical industry standards and will reflect experience

  • Free onsite parking

  • 25 days annual leave plus bank holidays (increasing in increments to 30 days after 6 years service)

  • Your birthday off work

  • Regular hours (including Christmas Day, Boxing Day and New Years Day off)


MAC Clinical Research invites applications from highly motivated candidates, with a desire to achieve their full potential. You will be working with an organisation that sees you as an investment and is keen for you to achieve your career aspirations.


Please note that if we receive a high volume of applications this date may be brought forwards.

Job Description - GMP Senior QA Associat
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