Our client, a manufacturing company based in county Limerick currently has an opportunity for a QA Specialist to join their team. This is a full time, permanent position offering an excellent salary and benefits package.
Main Responsibilities
- Prepare specifications and certificate of analysis;
- Release specifications and certificate of analysis when required;
- Verify product information upon preparation of the certificate of analysis;
- Pre-approve raw material COAs;
- Release raw material and packaging materials;
- Review and approve release work orders
- Help investigate quality complaints, Suggest improvements to SOPs.
- Coordinate with Quality Control for testing
- Coordinate with Quality Assurance Assistant on the GMPBULK label request.
- GMP responsibility for Quality Assurance should include as applicable but not necessarily be limited to:
- Releasing or rejecting all products including excipients, buffers and process solutions.
- Establishing a system to release or reject raw materials, intermediates, packaging and labelling materials;
- Reviewing of all documentation pertaining to the batch release process including production records and QC documentation
- Ensuring that nonconforming products and critical deviations are investigated and resolved in a timely manner;
- Reviewing and closing out of specification / out of trending investigations;
- Approving all specifications and master production documents;
- Ensuring that internal audits (self-inspections) are performed and that identified actions are closed in a timely manner;
- Qualification of suppliers for critical raw materials and packaging components
- Qualification of external service providers
- Approving changes via the change management process that potentially impact on product quality
- Reviewing and approving validation protocols and reports and supporting validation activities across the business
- Ensuring that quality-related complaints are investigated and resolved in a timely manner;
- Performing annual product quality reviews.
Education and Experience
- Bachelor’s degree or equivalent in Chemistry or a related science
- 3+ years of Quality Assurance Experience or equivalent (R)
- Technical writing ability (R)
- Knowledge of major Pharmacopoeial compendia (R)
- Knowledge of GMP, ICH and ISO guidelines (R)
- Team-work oriented (R)
- Sense of organization and priorities (R)
- Strong communication (oral and written); Ability to multi-task (R)
