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Product Release Administrator

3 months ago

Coleraine, United Kingdom Eakin Healthcare Group Full time

ABOUT THE ROLE


The Product Release Administrator will be a member of the Group Operations Compliance team, reporting to the Quality Assurance Manager, this is therefore an exciting opportunity to join a growing team and work closely with various functions.

As a key role in the Group Operations Compliance Team strategy, you will provide business support and guidance in line with the Group Operations Compliance and Eakin Healthcare Strategies.


With the role located at one of our three operations sites, this is an excellent opportunity for an individual to work closely with both site-based functions and wider colleagues across the Group Operations Compliance Team.


KEY ACTIVITIES

  • Implement, enhance, and maintain relevant processes as required by the quality management system regarding product release.
  • Positively interact with multiple functional areas including the Quality Compliance and Production teams to provide an efficient and effective service to support the timely release of finished medical devices to ensure schedules are maintained and material is readily available.
  • Oversee and coordinate the accurate completion, retention, and review of product release documentation, liaising where necessary with the relevant internal stakeholders.
  • Ensure all product release documentation complies with the appropriate site regulatory certification and standards (ISO13485, MDSAP, GMP, GDP, FDA CFR).
  • Identify discrepancies in documentation and report exceptions to appropriate departments for action. Where appropriate, ensures nonconformances are initiated for any product release documentation related events.
  • Liaise with stakeholders to remediate deficiencies to ensure timely completion of all followup actions for resolution to all product release documentation issues according to GMP standards.
  • Responsible for final batch disposition based on review of all associated documentation.

Quality System

  • Maintain files and records in accordance with relevant QMS procedures and make them available for review during Quality Audits.
  • Adheres to internal/external guidelines, specifications and regulatory requirements while reviewing batch documentation.
  • Assist the Quality department with Quality System/Product administration tasks as required.
  • Comply with all applicable QMS processes at all times.
  • Collaborate with the introduction/function/improvement of the product release program across all production areas and potentially other sites.

Health & Safety

  • Following all Health & Safety guidelines within the Department and notifying the Company of any incident, accident or near miss.

Other

  • To adhere to the company's Equal Opportunities policy and Dignity at work policy in all activities and to actively promote equality of opportunity wherever possible.
  • To be responsible for your own health and safety and that of your colleagues, in accordance with the company's' Health and Safety policy
  • To adhere to the company's Quality policy and Environmental policy
  • To undertake other duties as may be reasonably required.

KEY SKILLS

Essential

  • Meticulous with high levels of attention to detail
  • Strong command of written English
  • Excellent verbal communication skills
  • Excellent organisational and planning skills to deliver efficient, compliant product release with completion of subsequent documentation.
  • Ability to work unsupervised.
  • Ability to work well in a team.
  • Competent in the use of Microsoft office packages, specifically Excel, Word and Outlook.

Desirable

  • Experience of working in a product/batch release role in the medical device/pharmaceutical industry
  • Experience of working in a regulated manufacturing environment (e.g., ISO13485, MDSAP, ISO9001)
  • Experience in good documentation practices (GDP).

KEY WORKING RELATIONSHIPS

  • Quality and Operations

External

  • Notified Bodies and Competent Authorities

ADDITIONAL INFORMATION

  • Ability/willingness to travel to other Eakin Healthcare sites if required.

COMPETENCIES

Analytical - Enjoys analysing qualitative data but also considers quantitative and seeks to identify and explore they key elements in information before making commitments. Tends to like to use facts and figures when planning and reporting and is concerned about accuracy and detail.

Quality Orientation - Is precise, pays attention to details, checks things and ties up 'loose ends'. Has a strong conscience about getting things right and seeks to ensure that decisions and solutions do not involve undue risk, adheres to policy and standards.

Team Working - Enjoys participating in group activities and likes to work in close proximity with other people. Is ready to collaborate with and support others and is willing to co-operate and compromise for the overall good.

Following Directions - Is motivated to accept and comply with standards and instructions and has a strong conscience about delivering what