Quality , Science, Pharmaceutical & Food

QA Specialist- Batch Release

  • Contract
  • Remote
  • Cork
  • 41961338

PE Global is currently recruiting for a QA Specialist on behalf of our client based in Cork.

Role: QA Specialist 12 months – days – hybrid (3 days onsite, 2 days remote).  Role will support Batch Release activities

 

The have an exciting opportunity for a QA Specialist to join our expanding team in Cork to help support the Quality Operations unit and batch release team.

 

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.

 

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 • Ability to build relationships with Operations and other stakeholders

 

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 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 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 Quality Assurance team • Experience in direct interactions with regulatory agencies during site inspections.

 

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Interested candidates should submit an updated CV.

 

Please click the link below to apply, call Audrey on 0214297900 or alternatively send an up-to-date CV to audrey.mccarthy@peglobal.net

 

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***

 

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