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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

QA Specialist


Reference:rk4153 Location: Cork
Qualification:DegreeExperience:4-5 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Specialist

QA Specialist
RK 4153
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, C&Q and Validation activities, Data Integrity and CSV support, change control, non-conformance investigations, compliance auditing, and other related quality system elements.


Duties:


• Supports GMP activities from operational through to Laboratory support programs.

• Partners with other Departments to ensure that compliance programs are completed in an efficient manner and are effectively maintained.

• Responsible for implementation of systems and procedures for the management of change control and deviation management, as it applies to plant installations, systems, and operations in accordance with GMP.

• Quality oversight of project activities including but not limited to, C&Q activities and process validation through to commercial manufacture.

• 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.

• 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

• Experience in C&Q, Process validation, anddirect interactions with regulatory agencies during site inspections.


If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or [email protected] for further information.