QA Specialist

Orion Group Life Sciences are currently recruiting QA Specialist on behalf of our Multinational Pharmaceutical client based in Ringaskiddy, Cork on an initial 12-month contract.

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, supporting batch release activities, document review,, Data Integrity activities, change control, non-conformance investigations, compliance auditing, and other related quality system elements.

As a QA Specialist, your typical day may include:
* 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 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.
* Irregular Domestic and international travel may be required

Be vital:
* To Bachelor's 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 Quality Assurance team
* Experience in direct interactions with regulatory agencies during site inspections.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.