Area of Responsibilities

This position will interface with levels of the organization on a daily basis observing the site’s compliance to current Good Manufacturing Practices (cGMPs).  The successful candidate will manage the life cycle of computerized systems in manufacturing environmets. They will be capable of leading groups and independently working to establish quality management of computerized systems.

The following is a list of specific duties, which are considered to be essential functions of this job. This list is not all-inclusive, and the employee who occupies this position is expected to assume any/all duties assigned by management, irrespective of whether such duties are specifically included in this list. 

• Establish validation policies and procedures ensuring compliance with global regulations and corporate standards.
  • Management of computerized system validations, including system specifications, system architechure design, data integrity, user management, and risk analysis.
  • Work directly and indirectly with site management to schedule and execute validation activities to support the business plan.
  • Participate in Validation project teams.
  • Proactively identify and resolve validation issues
  • Author, execute and follow up closure documentation for Installation (IQ) Operational (OQ) and Performance (PQ) Qualifications. 
  • Be knowledgeable performing review, authoring and revisions of Standard Operating Procedures and related manufacturing process documentation. 
  • Perform duties related to the documentation and follow up to Corrective Preventative Action plans and Change Control. 
  • Provide validation support for the introduction of new equipment or modification of equipment. 
  • Preparation of summary reports, deficiency/discrepancy reports, gap analysis, risk analysis, failure mode & effect analysis, traceability matrices.
  • Knowledgeable in validation of pharmaceutical equipment including autoclaves, depyrogenation ovens, coolers, and other manufacturing equipment.
  • Assist with the development of such documents as: Validation Master Plans, Computerized System Validation, System Design Specifications, Users Requirements Specifications, Detailed Design Specifications.

Physical/Mental:

•       Continuous mental and/or visual attention to manufacturing functions

•       Must be able to handle multiple priorities at one time

•       Must be able to read, write and speak English

Business Environment:

•       Effective judgment in a fast-paced, results-orientated environment

Competences

Competences required to fulfil the area of responsibilities and work assignments:

Education: 

•       Minimum required: Bachelor’s Degree in Engineering or Science and minimum 5 year relevant experience performing validations in pharmaceutical/ manufacturing environment

Experience: 

•       Prior experience with cGMP activity required

• Experience with computerized system validations in a regulated environment 
• The ideal candidate must be willing to be held accountable and must work well with others in order to ensure that all objectives are met on a regular basis
• Excellent written and verbal communication skills
• Must be proficient in Microsoft Office applications, particularly Word and Excel
• Excellent scheduling and time management skills with daily operations and special projects
• Knowledge of cGMP, cGDP and cGLP
• Knowledge of scientific writing and terminology