• Posted date 30 November 2022
• LocationCounty Cork
• Job type Temp

• SalaryNegotiable
• Discipline Life Sciences
• ReferenceJO-2211-506269

Kenny-Whelan (A specialist division of the CPL group) are hiring QA specialists (to be based at our clients Biopharma facility in Brinny , West Cork.

Contact Jenn Dinan on 0860466583 and email jdinan@kenny-whelan.ie

The Quality Associate Specialist/ Specialist will provide Quality oversight, support and knowledge to activities relating to Quality Systems across the site and in meeting the Manufacturing Division Priorities of: Compliance, Supply, Strategy and Profit Plan.

Activities Within Role:

This role requires the delivery of a robust Quality Management System to support a flexible, collaborative, multi-skilled teamwork environment.

The team working style is one of collaboration, coaching and facilitation to ensure the success of the site. The Associate Specialist/ Specialist is accountable for the Quality Systems within the site.

JOB EXPERIENCE

• 1 - 5 years’ experience in the Pharmaceutical industry or a similar operating environment which includes experience in a Quality function
• Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (i.e. Quality, science etc.)
• Operational experience of at least 4 QMSs

QUALIFICATIONS

Degree or 3rd level qualification (Science, Quality)

SKILL SET

• Quality Assurance SME knowledge, from both operational and educational experience, is required
• Demonstrated use of Leadership Behaviours
• Knowledge and experience in interpreting current regulatory requirements and providing independent support to the site
• Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance
• Demonstrated ability to work and succeed within teams as well as leading small project teams
• Demonstrated ability to drive the completion of tasks
• Proven track record of providing independent Quality support to the site.
• Advanced PC skills such as Excel, Word, PowerPoint
• Stakeholder management of multiple decision makers, auditors, cross functional teams by demonstrating the ability to maintain and strengthen trust relationships with people on all levels
• Proven decision making capability with full accountability and responsibility
• Demonstrated coaching skills
• Demonstrated ability to solve problems
• Lean Six Sigma Yellow Belt or suitable alternative

Primary activities/responsibilities:

• Provides to the site knowledge and experience in Quality Systems and/or Operational Quality, including the following i.e. Quality Notifications/ Investigations/LIR coaching; GCM coaching, environmental monitoring program, sterility assurance/low bio-burden manufacturing, customer complaint investigations etc.
• Uses knowledge to improve Quality Systems, solve problems, provide continuous improvement and execute tasks.
• Provides compliance contribution to project teams and leads small projects.
• May coach and guide colleagues within the site.
• Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.
• Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
• Supports Corporate Quality to ensure actions related to Quality Systems and/or Operational Quality at the site are executed.
• Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable.
• Ensure supply of high quality product through the implementation and oversight of the Quality Management System for the site.
• Ensure the highest Quality, Compliance and Safety standards.
• The Associate Specialist/ Specialist will participate and comply with the MMD Quality Management System (QMS) requirements, including ownership.

All applications will be treated with the strictest of confidence

Contact Jenn Dinan on 0860466583 and email jdinan@kenny-whelan.ie