Senior Quality Operations Specialist

My client, a global biopharmaceutical company, is recruiting for a Senior Quality Operations Specialist to join their team. This is a full-time permanent position, their office is based in Dublin City Centre and there is Hybrid working!

The Senior Specialist, Quality Operations – GMP/GDP supports Quality Assurance (QA) activities related to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) compliance for Clinical and Commercial products, including Named Patient Supply. This involves working with cross-functional internal teams; Supply Chain; Technical Operations; Regulatory Affairs; Contract Manufacturing Organizations (CMOs) and Distribution Partners to implement, manage, maintain, and support quality assurance activities, including plans that contribute to the company’s ability to achieve and maintain regulatory compliance and ensure product quality for Clinical and Commercial Supplies/Named Patient Supply.

ESSENTIAL FUNCTIONS

Performs QA review and approval of documentation related to contract storage sites, distribution partners and transportation providers including but not limited to:

• Distribution Instructions, Named Patient Supply Protocols and Early Access Program Standard Operating Procedures (SOPs).
• Investigations, incidents, exceptions, deviations and risk assessments as generated by contract storage sites, distribution partners and transportation providers.

• Logistical complaints/vendor complaints.
• Evaluation of temperature excursions in accordance with SOPs.
• Ensures the successful submission of required paperwork, releases, and other related documents to the company’s partners for Commercial/Named Patient Supply product.
• Contributes to the conduct of the Customer Approval/re-validation process. This includes supporting the Responsible Person (RP) in preparing the required documentation.
• Supports Batch Disposition activities as required, including maintaining QA trackers/databases related to Batch Disposition.
• Provides support to Corporate QA for complaints, logistical investigations, APQR’s etc.

• Contributes to the management of the Change Control System by generating and reviewing Change Control documents for Clinical and Commercial product.
• Supports QP’s and RP’s in the completion of routine tasks as required.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

* Minimum level of education and years of relevant work experience.

Bachelor’s degree in a scientific discipline and a minimum 5 years of experience in QA or related role(s) in a pharmaceutical, biotechnology or related environment, at least 2 of which have been in a CMC-focused QA position.

* Special knowledge or skills needed and/or licenses or certificates required.

• Detailed/Demonstrated knowledge and understanding of GMP/GDP regulations and Food and Drug Administration (FDA) requirements.
• Demonstrated proficiency of commercial and clinical batch record review and experience of working with Contract Manufacturing organizations/Contract Storage Sites/Distribution Partners/Transportation partners.
• Experience in Quality Management Systems including Deviation Management, Out of Specifications, Change Control.

*Special knowledge or skills and/or licenses or certificates preferred.

• Experience in ERP systems.
• Analytical lab experience.
• Validation/manufacturing experience.

For more information and to apply for this role please call Zoe on +353 1 2784671 or e-mail zhamilton@thornshaw.com

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Www.thornshaw.com Tel: +353 1 2784671