Operational Compliance Officer

PURPOSE & SCOPE OF THE POSITION

The Operational Compliance Officer supports the manufacturing operations by focusing on batch review and QMS on time delivery.

 

PERSON SPECIFICATION

QUALIFICATIONS

  • Educated to degree level is essential
  • Educated to degree level in Life Sciences is desired

KNOWLEDGE

  • Experience within a regulated environment or equivalent is essential
  • Working to GMP, pharmaceuticals/biologics or relevant experience within a similar environment is desired

EXPERIENCE

  • Ability to follow and complete manufacturing documentation accurately is essential
  • Experience of a GMP controlled cleanroom environment is desirable
  • Knowledge of pharmaceutical manufacture is desirable

SKILLS

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

TO APPLY

If you are interested in applying for the role of Operational Compliance Officer at Symbiosis please send your CV and covering letter to Lorraine Den-Kaat by email to: Lorraine.Den-Kaat@symbiosis-pharma.com.

KEY accountabilities

OPERATIONAL EFFECTIVENESS

  • Nominated manufacturing QA and QP point of contact for batch records and QMS.
  • Responsible for ensuring that the facility is in an audit-ready’ state at all times.
  • Perceiving problems as they develop and communicate such to the Manufacturing Manager.
  • Supporting the manufacturing team by driving process improvement projects across the manufacturing department.
  • Completing technical manufacturing reports / drafts for clients and provide any other supporting documentation as required.

COMPLIANCE & QUALITY MANAGEMENT

  • Maintaining a clean and safe work place in accordance with GMP and Health & Safety guidance.
  • Assisting in the undertaking of technical reviews associated with Corrective Action/Preventative Action (CAPA), deviations (including investigations and out of specifications).
  • Undertaking the review of Batch Manufacturing Records including Component Preparation, Lyo, Visual Inspection and Labelling and Packaging.
  • Perform, write and/or investigate CAPA’s and deviations.
  • Ensuring training records are up to date and accurate as per current SOP revisions.

MANAGING RELATIONSHIPS 

  • Attend, participate and contribute to regular staff and management meetings, as necessary.
  • Invest in developing relationships with all staff to fully understand staff needs and communicate the needs of the Manufacturing Manager in order that we deliver to agreed standards and timescales.
  • Invest in developing relationships with the management team to ensure we are a high performing Manufacturing team and Symbiosis’ services meet expectations.
  • Acting as an ambassador for the company.

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