Description
RESPONSIBILITIES:*Responsible for Process Validation generation including pFMEA, IQ, OQ, PQ
*Resolution of Problems encountered during validation.
*Ensure Consistency in validation/qualification approach across systems and projects.
*Provide guidance and direction in the preparation and execution of validation activities.
*Be fully conversant and up to date with GMP requirements for site-wide regulatory body compliance.
ESSENTIAL:
*3rd Level Degree
*Minimum of 5 years Quality Assurance / Regulatory affairs experience.
*Experience in completing Process Validation's
*Proficient in the use of MS Word, Power-point and Excel.
*Ability to write standard operating procedures, training documents, and regulatory responses.
DESIRABLE:
*Six sigma Green or Black Belt Certified
*Experience of electronic production processes
*Experience in using Gamp 5 Software V and V Techniques