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Quality Assurance Specialist Tech Support

  • Job reference: 924695
  • Location: Dún Laoghaire, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences
  • Date posted: 04/04/2019

Orion group are recruiting a Quality Assurance Technical Support (Biotechnology/Pharmaceutical) on behalf of our Client based in Dublin, Ireland - 12-month contract

The Quality Assurance Technical Support (QA TS) Specialist is a senior position within the QA function which will typically report to a QA Senior Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility. QA TS Specialist will be required to understand and grasp a broad range of quality related competencies.
In addition to routine Quality Assurance duties, QA TS Specialist may be assigned specific oversight and responsibilities for key quality systems or processes and may also serve as a primary quality partner/point of contact for products or functional areas, including Supply Chain, Information Systems, Manufacturing, Process Development, Validation, Engineering and Quality Control. QA TS Specialist may be cross-trained and/or assigned additional project specific duties, including continuous improvement/operational excellence initiatives.

QA TS Specialist Responsibilities: (may perform some or all of these duties)
* Provide overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Quality Control, Supply Chain, Engineering, Information Systems), ensuring that programs, policies and procedures are robust and in keeping with regulatory and expectations.
* Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities whilst ensuring that all activities meet and regulatory expectations.
* Review and approve validation lifecycle documents, including Master-plans, protocols, reports and active participation during earlier phases of process design, Characterisation, Commissioning etc.
* Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring the scope of record is clear and implementation activities are robust and timely.
* Write, review and approve Standard Operating Procedures in accordance with Policies.
* Review and approval of Master Batch Records and SAP BOMS
* Quality SME reviewers/approvers for regulatory submissions, ensuring compliance with site and corporate procedures.
* Perform all activities in compliance with safety standards and SOPs
In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role
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
* Experience working in aseptic operations, protein formulation, vial and syringe filling.
* Experience working in QA Technical Support or validation functions, including experience of New Product Introductions, Technology Transfer and Process Validation activities
* Experience working with dynamic cross-functional teams and proven abilities in problem-solving and decision making
* Excellent written and verbal communication skills
* Strong organizational skills, including the ability to follow assignments through to completion
* Detailed Knowledge of applicable Regulatory requirements and experience with Regulatory Inspections.

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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