Quality Control Officer (x3)

The Quality Control Officer contributes to developing Symbiosis’ mutually beneficial relationships by:

• Focussing on responsibilities aligned with Quality Control activities within the Symbiosis organisation.
• Supporting the Quality Department and specifically the Quality Control function within Symbiosis and ensuring sampling, specifications and testing as well as the organisation, documentation and release procedures which ensure that the necessary and relevant tests are carried out.
• Ensuring adherence to all developed quality systems and promoting continual development of quality systems where necessary.

• Operational Quality Control and Testing
• Contribute to continual development of quality systems, in particular those relating to QC activities.
• Carry out Chemistry and / or Microbiology testing activities on raw material, in process and finished product as defined in the Pharmacopoeia (EP, BP, USP or JP) or client specific methods as directed by the Head of Quality Control.
• Review and approve data such as Environmental Monitoring and QC testing including but not limited to: LIMS data entry and extraction, report preparation, document handling, notification of Out of Specification results.
• Support stability study management and testing and QC analysis and reporting.
• Complete QMS administration for QC related issues including Out of Specification, non-conformances and environmental monitoring excursion investigations.
• Support the implementation or updates of new QC procedures throughout the company including the provision of training and other support across the Symbiosis organisation.
• Support implementation of analytical methods and tests as per appropriate regulatory guidance.
• Support the ongoing maintenance and management of subcontract facilities used within Symbiosis including audit management, maintenance of agreements and performance review.
• Support the maintenance and provision of QC related trend data as required by Symbiosis quality review processes and regulatory authorities.
• Support the Project Management function in the communication and consultation as required regarding testing requirements on behalf of Symbiosis clients.
• Undertake weekly, monthly, and annual equipment checks as defined in appropriate SOP’s.
• Undertake monthly data integrity checks.
• Approve and release incoming Raw Material
• Ensure completion of all relevant QMS documentation in a timely manner including non-conformances, OOS, corrective and preventative actions, change management, risk assessment and audit responses.

Provide regulatory support regarding QC analysis through consultation of the appropriate information sources eg GMP guides and Pharmacopoeias

Develop, monitor, improve and maintain procedures to ensure compliance with EU/FDA Good Manufacturing Practice for the manufacture and testing of pharmaceuticals

Ensure completion of all relevant QMS including management of non-conformances, corrective and preventative actions, change management, risk assessment and audit responses

• Communicate, meet with or chair a project planning meeting as appropriate with a representative from the relevant functional areas of the business and CROs to communicate project requirements and to prepare project plans for assigned projects.
• Perform a project handover with the Business Development department, ensuring that all elements of the project agreed up to that point are clearly understood and transferred.
• Support the Head of Project Management manage client complaints in conjunction with other business functions e.g., to ensure that issues are resolved in a timely manner.
• Participate in internal, external and client audits.

• Provide QC guidance for cross functional groups to ensure compliance.
• Provide support to management during third party audits.
• Train staff in QC related procedures and concepts as directed by management.
• Coordinate and provide training across functional groups in Quality Control procedures.

• Attending, participating and contributing to regular staff meetings, as necessary.
• Investing in developing relationships with all staff
• Investing in developing relationships with the management team to ensure we are a high performing team and Symbiosis’ services meet expectations.
• Acting as an ambassador for the company.

QUALIFICATION
• Educated to degree level in Life Sciences

KNOWLEDGE
• IT skills – Microsoft packages

EXPERIENCE
• Experience with QC release testing
• Experience with environmental monitoring of GMP cleanrooms

SKILLS
• Effective communication skills
• Flexible and adaptive team player
• Ability to perform multiple tasks effectively in a busy environment
• Effective planning and organisational skills