QA Specialist

Thornshaw Scientific Recruitment

View: 106

Update day: 26-02-2024

Location: Cork

Category: Pharmaceutical / Chemical / Biotech Science Labor

Industry:

Job type: Fixed term

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Job content

  • Posted date 16 April 2023
  • LocationCounty Cork
  • Job type Temp
  • SalaryNegotiable
  • Discipline Life Sciences
  • ReferenceJO-2304-513526

Cpl in partnership with our client Viatris are seeking a QA Specialist to join the team for a fixed term contract in Little Island, Cork.


QA Specialist


Position Overview:

Perform quality assurance support functions by interacting with manufacturing and quality control colleagues regarding quality matters daily. Assure documentation maintenance as required by Corporate, Regulatory and site procedures and GMP regulations.

Periodically audit site, suppliers, or other Viatris sites’ procedures and documentation for adherence to ICH and cGMP regulatory commitments and Viatris policies/procedures.


Responsibilities of the role:

The following describes the full area of responsibility of the QA Specialist role. Individual QA Specialists may fulfil some or all of these areas of responsibility.

  • Ensure all product is manufactured, tested, and released in compliance with ICHQ7a and Viatris requirements by:
  • Review and approval of master batch records and executed batch records to assure compliance with regulatory standards and regulatory filing
  • Disposition of intermediates and API
  • Review and approval of deviations, change controls, SOPs, out of compliances, lab investigations and cleaning batch records.
  • Lead internal audits and reviews of manufacturing operations and quality systems to ensure compliance with cGMPs and other regulatory requirements
  • Assist with regulatory inspections
  • Assist with the development and delivery of cGMP training
  • Assure site compliance with CGMPs and Corporate Policies/Procedures.
  • Provide Quality Assurance Support for Validation
  • Maintain knowledge of regulatory environment, ICH, cGMPS, FDA and EMA
  • Policy and current industry trends. Provide technical expertise to colleagues regarding the interpretation and/or implementation of cGMP matters.
  • Maintain appropriate EHS standards

The minimum qualifications for this role are:

  • Education: Bachelor’s Degree in Pharmacy, Chemistry, Chemical Engineering, or another related field

Experience/Skills:

  • 3+ years of experience in pharmaceutical manufacturing product development, quality control and/or cGMP compliance
  • Experience in collaborative working and problem-solving.
  • Strong technical, analytical, and problem-solving skills with the ability to make timely decisions.
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Deadline: 11-04-2024

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