Industry : Pharmaceutical
Quality Support to Production and Warehouse activities including batch record review, in process checks, sampling, documentation review and process audits to ensure batches are manufactured in compliance with regulatory requirements, company policy and procedures.
Essential Duties and Responsibilities include, but are not limited to, the following:
- Support to batch manufacture including line sign-off prior to start of batch manufacture, performing in process checks during batch manufacture.
- Perform routine review of documentation such as Batch records, logbooks, forms, protocols, reports, COAs, etc. generated to support commercial and development batches for accuracy, completeness, and compliance to GMP and procedural requirements.
- Review of Standard Operation Procedures for manufacturing operations and cleaning.
- Participate in any investigations related to manufacturing.
- Prepare Standard Operating Procedures, investigations, reports and forms as required.
- Perform swab sampling (chemical).
- Perform process audits. Monitoring of GMP compliance during production activities.
- Monitor documentation errors and work with personnel to correct documentation, as needed, and develop preventive actions to reduce or eliminate recurrences.
- Management of retain samples.
- Sampling and inspection activities.
- Issuance of documentation for production – Batch Record, SOPs etc.
- Support Training activities – preparation / execution of on-the-job training.
- Support Warehouse activities as required.
- Support the Head of Quality/Designee during regulatory/customer/corporate audits as required.
Role Education & Experience:
Adequate Experience on Pharmaceutical GMP environment accredited with HPRA and FDA.
Contract Duration: Permanent
Location: Co Tipperary.