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QA Specialist

  • Job reference: 930185
  • Location: Cork
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 24/02/2020

Orion Group Life Sciences have an exciting opportunity for a QA Specialist for our Multinational Pharmaceutical client based in the Cork area on an initial 10-month contract.

Job Purpose

Quality and Compliance specialist ensuring quality standards are achieved and maintained at suppliers through supporting management, and oversight on Quality Operations functions for external business partners.

This support includes ensuring continuous compliance with relevant regulatory health authority requirements, effective risk management, strategy development and execution, and effective collaboration between R&D, Operations, Procurement, TechOps, Regulatory Affairs and other technical disciplines (EHS). Functions and activities include quality assurance review functions (such as Change Control, Quality Issue Management, compliance audit activities, supporting creation and management of risk mitigation plans for suppliers.

Main Responsibilities of the role

  • Support of planning, execution, and documentation of the qualification and monitoring for suppliers who are sourcing APIs, API materials or DP materials such as excipients, raw or packaging materials, to Supply Chain for the manufacture of Intermediates, APIs, or drug products respectively
  • Support Surveillance on the quality and compliance status for all suppliers of raw materials, packaging materials, intermediates, excipients, and APIs
  • Support of Management of Change related to supplier (change assessor, action executioner)
  • Assessment of deviations, corrective and preventative actions (CAPAs), and complaints concerning materials received from suppliers
  • Provision of all information needed for the release/reject of suppliers in SAP (SAP master data) and SAP Material approval /AML updates for LM
  • Support Establishment of Quality requirements and Quality agreements and periodic review of Quality Agreements
  • Support account owners for initial assessment and qualification of suppliers for new product introductions, and establishment of initial Qualification Statements
  • Support Periodic performance measurement for suppliers
  • Provide support to the local Site during Customer and HA inspections as needed
  • Support supplier Specification agreement and approval management
  • In conjunction with Account owners he/she collaborates with internal operating companies and R&D partners on a wide variety of product, process, project and compliance related issues
  • Interfaces with internal lient functional groups to broker the necessary technical support for external partners. Interactions are required with Tech Ops, PDMS, Procurement, EHS, Planning, the different manufacturing sites, but also with the other quality groups within the company and on enterprise level, such as Compliance, Quality unit API manufacturing, Quality systems and the different Qualified persons.

Desired Experience and Background of the successful candidate

  • BSc/MSc/Phd and 3 years of experience in quality management, production, quality control, or R&D in a pharmaceutical and/or biotechnology environment
  • Familiar with GMP - and International Conference on Harmonization ( ICH ) - regulation
  • Trackwise and SAP experience would be desirable
  • Exposure to regulatory authorities' inspections

    #pharmaceutical #medical #multinational #product #qualityassurance

For more information on this role, call Daniel Ryan on +353868140295 or email for a completely confidential chat about this role and other opportunities using the reference number: 930185

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.

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