Excellent 24 month contract opportunity with a leading Pharmaceutical company in Cork.
This position is responsible for carrying out tasks and projects related to management of Quality Assurance activities in a GMP environment.
This role will provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met.
Key duties include:
- Partnering with other Departments to ensure that compliance systems are implemented in an efficient manner.
- Batch Record Review & material release to ensure compliance with GMP requirements.
- Carries out tasks related to the administration of event management systems including Review & Approval of Event, Deviations, and Customer complaints.
- Carries out tasks related to the management of batch records design and approval.
- Carries out tasks relating to the management of site change control systems.
- Compiles Annual Product Reviews.
- Supports all validation activities on site and approves and compiles where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.).
- Supports system qualification and process validation activities.
- Reviews and approves SOPs/work instructions/forms from other departments on behalf of Quality Assurance
- Co-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site.
- Participates in the introduction of new process or modified process steps, as part of a New Product Introduction Team (NPI)
- Perform GMP audits on-site and vendor facilities as required.
- Carries out tasks related to the administration of site supplier approval process.
If you would like to hear more, or if you would like to be considered for this role, click the 'Apply Now' button below or get in touch on 021 2300 412 or firstname.lastname@example.org
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.