Quality , Science, Pharmaceutical & Food
Quality Specialist – Doc Control
PE Global is currently recruiting for an Associate Quality Specialist – Doc Control on behalf of our client based in Cork.
This is an initial 11 month contract role. – shift
Quality oversight, support and knowledge to activities relating to Quality Documentation System across the site and in meeting the priorities of: Compliance, Supply, Strategy and Profit Plan.
The team working style is one of collaboration, coaching and facilitation to ensure the success of the site. The Associate Quality Specialist is accountable for the Quality Documentation System within the site.
This role requires the delivery of a robust Quality Documentation System to support a flexible, collaborative, multi-skilled teamwork environment.
(Functions include, but are not limited to, the following)
- The Quality Specialist will have proven capability in the development and maintenance of Quality Documentation Systems. The successful candidate will be an active member of cross functional teams, and be focused on delivering and championing process improvement. The Quality Specialist will model the Leadership behaviours and understand the MPS principles to drive a culture of continuous improvement building a High-Performance Organisation.
- The Quality Specialist will participate and comply with the Quality Management System (QMS) requirements, including ownership.
- Provides to the site knowledge and experience in Quality Documentation Systems.
- Responsible for the Site Documentation System including Issuance, reconciliation, storage, archiving and retrevial of cGMP documentation to support the manufacture & testing of our products.
- Responsible for maintaining the Site Master file for current effective cGMP documents on site
- Uses knowledge to improve Quality Documentation Systems, solve problems, provide continuous improvement and execute tasks.
- Provides compliance contribution to project teams and leads small projects.
- Complete documentation audits.
- Coaches and guides colleagues within the site.
- Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.
- Responds to non-standard requests from customer needs.
- 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 at the site are executed.
- Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable.
- Ensures supply of high quality product through the implementation and oversight of the Quality Documentation System for the site.
- Champion the highest Quality and Compliance standards for the site.
- Ensure highest safety standards.
- Additional activities as requested by QA Lead
Qualifications & Education
- A qualification in a quality discipline is desired with 1-2 years pharmaceutical / documentation experience. However a combination of experience and/or education will be taken into consideration.
- Experience in a similar regulated documentation role is strongly preferred.
- cGMP documentation control SME knowledge, from both operational and educational experience, is required.
- Must possess excellent communication skills (verbal & written). Must have excellent organizational (Time Management) skills, attention to detail and computer skills including Excel, Word and Sharepoint. Be able to work as a flexible member of a Quality team.
- Ability to collate and control GMP documentation.
- Strong proven attention to detail is necessary to be successful in this team.
- Good organisational skills are required with an ability to manage multiple priorities.
- Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance.
- Understand the business needs and customer asks. Know how to prioritise requests.
- Demonstrated ability to drive the completion of tasks.
- 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.
- Energetic with proactive & positive attitude.
- Desirable evidence of Continuous Professional Development.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Audrey on 0214297900 or alternatively send an up-to-date CV to firstname.lastname@example.org
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***