Description
RESPONSIBILITIES:- Support plant, process and software validation review and deviation activities in a Medical Device regulated environment
- Identify deviations from established product or process standards and provide recommendations for resolving
- Analyse validation test data to determine whether systems or processes have met validation. Help resolve problems encountered during validation.
- Ensure Consistency in validation/qualification approach across systems and projects.
- Provide guidance and direction in the completion of validation activities.
- Be fully conversant and up to date with GMP requirements for site-wide regulatory body compliance.
- Conduct Periodic Reviews of validation performance and make recommendations to improve and streamline the process
- Ensure correct use and review of the change control process in relation to Validation requirements
- Help determine process capability of new equipment
ESSENTIAL SKILLS AND EXPERIENCE:
- Degree Educated in relevant Science or Engineering discipline
- Minimum of 4 years Quality Assurance / Regulatory affairs experience
- Experience in working within a Medical Device Manufacturing Environment.
- Six sigma Green or Black Belt Certified
- Experience in completing Process Validation's as per CDRH Guidance
- Experience in using Gamp 4 or Gamp 5 Software V and V Techniques
- Sound understanding and utilization of Problem Solving Techniques
- Good computer skills (MS Word, Power-point and Excel)
- Experience writing standard operating procedures, training documents, and regulatory responses.
- Experience in statistical Analysis / MSA / DOE / DMAIC and problem solving methods.
- Experience writing test plans, project plans, procedures and project schedules.
- Experience reviewing Functional Requirements, Design Specifications, FAT's, SAT's, IQ's, OQ's, PQ's.
- Knowledge of cGMP, Cleaning, Process and Product Validation requirements and techniques.