Computer Systems Validation Associate

CooperVision, a division of CooperCompanies (NYSE:COO), is one of the world’s leading manufacturers of soft contact lenses. The Company produces a full array of daily disposable, two-week and monthly contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism, presbyopia and childhood myopia; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visit www.coopervision.com

Job title: Quality Assurance Software Validation Specialist

Location: Mount Park, Eastleigh, Hampshire

Scope:

The Computer systems Validation Associate will be responsible for management of all CSV document control activities at the assigned site. Regular interaction with different functional departments including MFG, Global Packaging, Supply Chain, IT, etc. as they interact with the CSV Team and use eQMS system (Agile).

Job Summary:

To execute required QA review activities for change control elements associated with local and global departments in support of the Quality Management System, Computer Systems Validation (CSV).

To revise and create Standard Operating Procedures (SOP’s), Work Instructions (WI’s), Design Specifications and other controlled documents in collaboration with process owners and subject matter experts for CSV.

To utilize the Agile electronic Quality Management System (eQMS). Process these documents and obtain approvals as well as review Change Orders and support training. Required to work on QA project in a support function that may include travel.

Essential Functions & Accountabilities:

• Understands the CSV framework and helps and support the implementation of validated systems.
• Act as change analyst for CSV Document Change Orders (DCO’s) and Deviations for all controlled documents within assigned departments.
• Manages Training positions and roles in Agile for assigned CSV local and Global departments.
• May assist with process audits to verify conformance with standard operating procedures. This will include revising and or creating SOPs as directed.
• Regularly provides workload status and updates to CSV Specialist.
• Communicates information effectively from other departments and to the CSV team.
• Seeks to learn Good Manufacturing Practices (GMP) regulations and industry standards as well as ISO general guidelines.
• Data entry and analysis into computer based collection systems (Access, Excel & Agile).
• Performs archiving as necessary as it applies to quality records. May assist in all aspects of record retention and retrieval. May act as Administrator for record retention activities.
• Perform duties for the annual Quality Systems Regulation (QSR) retraining as required by the quality management system.
• As business needs dictate, works extended hours to complete daily department goals or tasks, to include mandatory overtime.
• Performs other assignments related to the department as directed by Leadership.
• Support Global IT from QA review perspective for Computer Systems validation and provide guidance on requirements to ensure compliance with software development lifecycle and CooperVision policies and procedures.
• Works to support computer systems validation across our European sites.

CooperVision’s management team is committed to the development of and implementation of the quality management system and maintaining its effectiveness by communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements.

Travel Requirements:

Travel might be required to support regional and global quality support of projects and initiatives.

Qualifications

Knowledge, Skills and Abilities:

• Working of knowledge of Microsoft Office Suite. Experience with Agile preferred. Should possess skills to utilize the concept of continuous improvement, change management and employee teams.
• Ability to work with a diverse workforce.
• Knowledge of Quality Assurance regulations and methodologies, including Good Documentation Practices.
• Good analytical and problem-solving skills.
• Excellent written, oral and interpersonal communications skills.
• Excellent time management.
• Self-motivated and attentive to detail.

Work Environment:

• Office working environment.
• Ability to perform light to medium physical work and standing for long periods of time, if required and depending on the task.

Experience:

• 1 years of experience with document control desirable but not essential.
• Medical Device industry experience preferred; other regulated industry experience considered.

Education:

• General School/College education, good numerical, written and communication skills.

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