External Quality Assurance Specialist

Location
Dublin, Republic of Ireland
Salary
Negotiable
Posted
01 Jan 2021
Closes
15 Jan 2021
Ref
EQAS
Contact
Chris Cahill
Discipline
Quality
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Overview

The External QUALITY Specialist is responsible for ensuring that all products managed by External Quality Assurance (EQA) are manufactured, packaged, analyzed, released, stored, and distributed in accordance with expectations and all applicable regulatory requirements.

Incumbent will have responsibility for External Party / External Partner (EP/ExP) operations related to the quality of products produced, under the oversight and guidance of the Product Quality Manager Lead - EQA. Role has primary batch release responsibility. Incumbent will ensure that effective and robust Quality systems are in place to comply with required regulations, policies and guidelines governing the EP/ExP's manufacture and release of (API intermediates, API) by means of risk-based quality oversight and on-site supervision, as appropriate.

Primary Activities include, but are not limited to the following:

* Evaluate and/or release products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations; review and approve changes to master batch records

* Manage routine deviations and complaints, and assist in the coordination of significant investigations including Fact Findings; assist in the coordination of any product recall involving the external manufacturer

* Provide guidance to the partner on conducting investigations of batch rejection, atypical events, customer complaints, etc. where warranted

* Provide support for audits of EP/ExP by regulatory agencies; review audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are warranted

* Support routine analytical change requests and support process modification change controls

* Annual Product Review assembly

* Support document requests for regulatory filings and post approval changes

* Gap remediation plans, Quality Risk Management data inputs, and data integrity gap assessments

* Receive and share Quality Alerts and Quality Bulletins with EP/ExP

* Closely collaborate with appropriate business/operations and technical areas to achieve company objectives.

* Ensure both operational knowledge and technical skills are maintained and compliant against individual training requirements

Education/Experience

  • You are likely to have a BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) preferred.
  • Minimum of 5 years' experience in the pharmaceutical industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.
  • Competent in analyzing complex product, production and testing issues and have demonstrated scientific problem solving capabilities.
  • Possess strong compliance mindset, demonstrated interpersonal skills, including leadership and coaching, motivation, communication and negotiation.

Typical Minimum Education Qualifications:

  • BSc Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) preferred.

Typical Minimum Experience:

  • Minimum of 5 years' experience in the pharmaceutical industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.

Technical Skills:

  • Possess a combination of analytical/scientific skills in order to effectively manage and control all activities necessary to support a total Quality Operations program governing external parties/partners that manufacture, package, analyze, release, store and/or distribute company product.
  • Experience in SAP and Trackwise
  • Thorough knowledge of all aspects of EM management, supply chain, and operations
  • A broad knowledge of manufacturing operations, including engineering, materials, R&D, production, etc.
  • Lean Six Sigma / Merck Production Systems training

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