Quality Assurance Specialist Senior 28950A
⦁ JobTitle: Quality Assurance Specialist Senior 28950A
⦁ About Company: Our client based in Dun Laoghaire is seeking a Quality Assurance Specialist Senior to join its expanding team
⦁ Duration of Role: 12 Months
⦁ Summary Objective: QA TS Specialist will be required to understand and grasp a broad range of quality related competencies.
⦁ Job 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.
• Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities.
• 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 scope of record is clear and implementation activities are robust and timely.
• Write, review and approve Standard Operating Procedures.
• Review and approval of Master Batch Records and SAP BOMS
• Quality SME reviewers/approvers for regulatory submissions, ensuring compliance with site and corporate procedures.
Skills and requirements
• University degree. Engineering or Science related discipline preferred.
• Relevant experience (5yrs +) working in the pharmaceutical or biotechnology industry ideally, however candidates from clinical, med device would be consideration but they would need to have aptitude, self motivated with a QA or validation background
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 ability to follow assignments through to completion
Benefits of working with Independent Solutions
> Excellent Team of Colleagues
> Access to high-value projects
> Excellent Technical Project Managers
> Excellent pay & conditions
Independent Solutions are Approved Suppliers for Multinational Pharma Biotech, Medical Device, clients with locations based here in Ireland.
At Independent Solutions, we will not require you to become an employee of Independent Solutions, we will facilitate and support you to become an independent contractor, thereby reaping the maximum rewards from your contract role.
We work in the area, we know the business, we are not a recruitment agency!
We continue to partner and grow our client base and thereby ensure that we have continuous supply of excellent roles
Yes, of course we benefit from having YOU with US, but we can assure YOU that YOU too will benefit …
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Tel: +353 1 5311 280
Fax: +353 1 5311 285