Senior Quality Specialist
|Job Title:||Senior Quality Specialist|
|Contact Name:||Larry O’Leary|
|Job Published:||over 1 year ago|
Required to manage and develop a high performing team of Quality Specialists working on project based activities, ensuring regulatory compliance to GMP and FDA guidelines with our client, a multinational healthcare company.
The successful candidate will provide Quality expertise on project activities, varying from New Product Introductions to Process Changes ensuring efficient and effective alignment and compliance with company policies and procedures, the corporate Quality System and regulatory requirements
Responsibilities for Senior Quality Specialist:
Drive and implement process improvements to ensure predictable processes across all product lines.
Provide functional expertise to other support functions on quality related issues.
Approval of change requests for product, process and quality system changes.
Ensure appropriate focus on customer complaint analysis and trending through product commercialisation - taking action where required.
Lead a diverse scope and complexity of problem solving activity where analysis of data requires evaluation of identifiable factors.
Define appropriate process and product validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
Support compilation of required Regulatory documentation.
Champion key Quality Metrics for the Quality project team CAPA, Quality Incidents, manufacturing complaints, RFT, Audit results etc.
Support the implementation of Lean Manufacturing across the site, in particular in new process development areas.
Work with Quality management to ensure appropriate project Quality resources are in place to support the project activity.
Requirements for Senior Quality Specialist:
Honors Bachelor's Degree (level 8) in relevant Engineering / Science degree
5+ years' experience within the FDA manufacturing industry.
2+ years people management experience or project management experience is highly desirable.
Strong knowledge and experience of utilizing quality principles and methods in a manufacturing environment.
Excellent interpersonal and communication skills with good leadership abilities.
Ability to work as part of a team and meet targets/goals efficiently.
Excellent analytical and problem solving skills.
Please contact; Larry on 01-2302400 / firstname.lastname@example.org
The RFT Group: Biopharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie / www.meddevicejobs.ie
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Key Words; FDA, GMP, Engineering, Engineer, Quality Supervisor, QA team Lead, Quality Assurance, Quality Engineering, Senior Quality Engineer, QA Engineer, Quality Management, Compliance, Six Sigma, Process Validation, CAPA, DOE, Pharma, Medical Devices, Munster, Cork, Waterford, Ireland.