Description
Job Title: QA Specialist
Job Duration: 18 Months
Job Location: Cork, IRL
Job Purpose
We have an exciting opportunity for a QA Specialist to join our expanding team in Cork to help support the Quality Operations unit.
The QA Specialist will be responsible for the following.
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.
You will have fulfilled the educational requirements for this role and have experience in a similar role within a FDA/EMEA regulated environment.
What you're great at:
Excellent interpersonal skills
Ability to operate as part of a team is critical.
Customer focus
Innovative
Excellent communication skills both written and verbal
Attention to detail
Good problem solving skills
Results and performance driven
Adaptable and flexible
Integrity, trustworthiness and objectivity
Knowledgeable of FDA/EMEA regulatory requirements
As a QA Specialist, your typical day may include:
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 of JSCI 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.
Be vital:
To Bachelors Degree in a scientific/technical discipline required
A minimum of 5 years experience in a quality or compliance role within the biological and/or pharmaceutical industry.
Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.
Focus on patients and customers at all times.
Desirable:
Advanced degree (MS, MBA, PhD) preferred
Experience in C&Q, and Process validation
Experience in direct interactions with regulatory agencies during site inspections.