QA Specialist
RK 3797
Contract – 12 months
Cork
We're currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Responsible for managing compliance activities and QA operational activities related to operational project as required by Good Manufacturing Practice (GMP). These activities include, supporting batch release activities, document review, Data Integrity activities, change control, non-conformance investigations, compliance auditing, and other related quality system elements.
Duties:
• Supports GMP activities from operational through to batch release activities.
• Partners with other Departments to ensure that compliance programs are completed in an efficient manner and are effectively maintained.
• Responsible for implementation of improvements and procedures for the management of change control and deviation management.
• Quality oversight of project activities including but not limited to, improvements within the batch release team, data integrity and system improvements.
• Participates as a key quality member in inspections and audits by external parties/agencies.
• Key participant within the QA team in the execution of their duties.
• Executes the activities of the group within quality to create a synergistic approach to goals and tasks.
• Irregular Domestic and international travel may be required
Experience and Education:
• Bachelors Degree in a scientific/technical discipline required
• 5 years of relevant work experience
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals
If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or rachel.kent@lifescience.ie for further information.