Role Summary:

The QA Validation Engineer plays a key role in the planning and execution of validation activities related to new product introductions, product transfers, new technologies and process changes. Provides support for the validation activities associated with equipment, test methods & processes ensuring that all compliance issues and requirements of Company validation policies and procedures are addressed. Provides support for the periodic validation reviews and administration of the site validation master plan and registry.

Principle Responsibilities:

• Ensure validation activities completed comply with US and EU relations, GBSC procedures and EHS requirements.
•  Review and approve documents prepared by project teams, other departments and contractor organizations (e.g. protocols, reports, change controls)
• Assist in development of validation strategy and validation plan for equipment and process validations.
• Assist in the development of sampling plans, test plans and data analysis related to process validation.
• Assist in resolution of deviations/ exceptions during qualification activities
• Assist with change control activities in accordance with site procedures.
• Prepare periodic validation review documentation for approval by the business units.
• Maintain site validation registry.
• Attend identified training, required to fulfil the role of QA Validation Engineer
• Support the QA Validation team leader in driving improvements within the Validation and Change Control processes to streamline the validation activities associated with Process Changes, Product Transfers and/or New Product Introductions.
• Participate in cross-functional teams as required.

Other related duties:

• Process/Quality input for validation processes and new product introduction.
• Adherence to site validation procedures and regulatory requirements.
• Adherence to company procedures as detailed in Quality Manual.

Qualifications & Experience:

• Hons. Degree Quality/ Manufacturing / Engineering / Science
• Minimum of 2 years’ experience in Quality Assurance/Engineering within regulated industry.
• Minimum of 1 years’ experience in Process, Equipment and Test Method Validation
• Working knowledge of Quality systems (FDA/ISO) within a regulated environment.
• High understanding of Validation practices including the equipment life cycle and regulatory expectations
• Ability to analyze Capability data using MINITAB
• Ability to interpret Engineering drawings/specifications
• Familiarity in areas of various inspection techniques
• Excellent interpersonal & communication skills

DESIRABLE:

• In depth knowledge of 21 CFR 820, 21 CFR 11, ISO 13485 and European regulations associated with the medical device industry