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Quality Assurance Specialist (Senior)

  • Job reference: 923529
  • Location: Dún Laoghaire, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences
  • Date posted: 24/01/2019

Orion group are recruiting a Quality Assurance Specialist (Senior) on behalf of our

Multinational Biotechnology Client based in Ireland-12-month Contract

Please note due to the nature of the role all applicants will need to have an eye examination prior to an offer being made.

Key Responsibilities
* Provide Subject Matter Expertise in relation to the testing of primary and packaging components for use in the manufacture of aseptic products.
* Approve IQA Incoming test results.
* Manage the introduction of new techniques and equipment to QA Incoming, including method transfers, and validations
* Write protocols and perform validation and equipment qualification/verification.
* Assume ownership and/or oversight of change control and NC/CAPA records; ensuring the scope of record is clear and implementation activities are robust and timely.
* Plan to perform routine analyses with efficiency and accuracy
* Compile and Analyse Metrics related to testing and disposition times for IQA
* Analyse Defect Data from Incoming and Finished Product Inspection.
* Generate Acceptance Sampling Plans to Justify the acceptability of products.
* Compile Technical Reports.
* Write, review and approve Standard Operating Procedures in accordance with company Policies.
* Participate in customer complaint investigations with suppliers of components and packaging.
* Provide training and advice to staff in relation to the testing of components.
* Actively participate in audits and their preparation.
* Evaluate practices for compliance and operational excellence improvement on a continuous basis.
* Perform all activities in compliance with safety standards and SOPs
* Ensure all GMP compliance training is up to date before performing GMP activities and participate in the training of new colleagues
* Perform all tasks with due care and attention and in accordance with Good Manufacturing Practices and the company requirements, policies and procedures.
* Act as a designee for the Supplier Quality Management role and Sr. Management role within the group

Basic Qualifications

* University degree. Engineering or Science related discipline preferred.
* Relevant experience (8yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
Preferred Qualifications and Experience
* Excellent written and verbal communication skills
* Experience working with dynamic cross-functional teams and proven abilities in decision making
* Project management or strong organizational skills, including the ability to follow assignments through to completion
* Demonstrated ability in problem-solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations
* Detailed Knowledge of applicable Regulatory requirements. Experience with Regulatory Inspections.
* Experience working in aseptic operations, protein formulation, vial and syringe filling.
* Use of Minitab, Excel and Smart Sheets

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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