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Quality Systems Coordinator

Requisition ID:  35601
Date:  Jul 9, 2021
Location: 

Dublin, Leinster, IE

Department:  Operations

 

 

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

 

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

 

Summary: 

The Quality System Coordinator’s role includes the primary responsibilities of administration of the site documentation control System, MasterControl including support for software updates and validation activities relating to MasterControl, and act as the Document Controller. Central to this role will be the provision of ongoing support to the wider business as MasterControl trainer; including document release, coordination of the annual review, creation of document and form templates, Quality System documentation filing system creation and management including off-site storage oversight. The Quality System Coordinator will also provide support and coordinate all document change request activities for documentation of their nominated area of responsibility. The role will be responsible for performing data analysis and reporting of Quality System Metrics and be a team member of ongoing Quality projects as required. Reporting to the Quality Systems Senior Coordinator.

                                                 

Requirements:

  • Relevant third level qualification combined with 1-2 years of demonstrated experience in the administration of Quality Systems, or a combination of education and experience. 
  • Must have 5+ years’ work experience in medical device or pharmaceutical manufacturing environment.
  1. Must have a working knowledge of design control processes. A background in drug handling would be considered an advantage.
  2. A thorough working knowledge of quality systems such as ISO 13485, 21 CFR Part 820 and/or EU GMP is essential. Knowledge of 21 CFR Part 210 / 211 would be considered an advantage.
  • Must have excellent communication and written skills
  1. Auditing experience to the requirements of ISO 13485 / 21 CFR Part 820/EU GMP is preferred. Auditing experience to CFR 21 Part 820, and / or CFR 21 Part 11 is considered an advantage.
  2. Must be able to work in a fast paced environment.
  3. Must be able to travel as required by the position.
  4. Must be able to organize and prioritize tasks; must be detail orientated and self-motivated.
  5. An ability to collaborate across functional lines and work effectively in a team environment.
  6. Must be able to work independently on own projects while working concurrently with all departments
               
     
    Essential Duties and Responsibilities:
     
  • Documentation Controller
  • MasterControl Sub-Administrator
  • Support for MasterControl Software Updates and validation where required
  • Management of off-site Archiving of controlled documents
  • Ensure compliance with QMS procedures, protocols and systems
  • Lead Auditor for Internal Quality Audit System
  • Participation in External Audit System if requested
  • Support in preparation and hosting of Third Party Audits including audit training, control room setup, general audit readiness throughout the business and post audit follow up.
  • Support in GMP Training preparation and execution including GMP Induction Program, annual site GMP Training and training in QMS Processes where required.
  • Support in generation of data for Management Review
  • Reporting of Monthly KPIs both internally and to corporate.
  • QMS compliance tracking & trending of issues and patterns to drive improvement
  • Co-ordinate activities associated with change management compliance
  • Act in accordance with the company’s Guiding Principles and adherence to the Corporate Code of Conduct Compliance to all local site Environmental, Health and Safety regulations
  • Compliance to all local site company policies, procedures and corporate policies.
  • Perform additional duties at the request of the direct supervisor.

 

 

Delegation of Duties:

 

When absent from the site, duties and responsibilities will be delegated to the following designates

  • Quality Systems Senior Coordinator or

Alternate Quality Systems Coordinator

 

 

 

 

 

 

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to kimberley.eby@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

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