Develops and implements validation and qualification policies, procedures and protocols.
Reviews and analyses protocol data to determine if requirements are met.
Prepares and submits protocol reports for internal and customer review.
Champions the change control process for critical equipment and systems.
Recommends corrective action where necessary and develops master validation plans.
Key Responsibilities and End Results:
Develops validation and qualification protocols and tracks execution of protocols in support of project timelines.
Develops & executes validations through all phases i.e.
FAT, IQ, SAT, OQ & PQ.
Review & Approval of validation documentation to ensure that site validation requirements are met.
Reviews and analyses protocol data to determine if requirements are met.
Resolves discrepancies and deviations during protocol execution.
Prepares and submits validation reports for internal and customer review and approval.
Coordinates and manages the validation and qualification strategy for equipment and processes.
Maintains and administrates the change control program for critical equipment and systems.
Evaluates, makes recommendations and implements improvements to the validation and qualification program as part of continual improvement activities.
Develops and maintains validation and qualification system level documents including master validation plans, policies and procedures.
Understanding of statistical techniques, e.g.
Process Capability & Gauge RR etc.
May be required to travel as per the requirements of the project.
Constantly seeks to improve work processes; Has a quality-first mentality; Learns from internal and external best practices to apply to her/his work.
Supports all company Lean Manufacturing principles.
Supports all company quality programs and initiatives.
Timeliness in addressing Quality System Requirements.
Principles of data integrity must be strictly adhered to.
All activities to be performed in strict accordance with the Quality Management System.
Role model and promote the organisations Values & Behaviours.
Must take personal accountability for your own safety.
Support culture of safety management through compliance with all safety policies, safety observation reporting and proactive involvement in Jabil AIM and Safety First programmes.
100% Compliance on Monthly Safety Procedures Training.
Ensures compliance with all company policies and practices in areas such as safety and all regulatory compliance.
Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.
Job Specifications:
BS in Engineering or Equivalent.
- 6 years of experience in validation or qualification in healthcare or other regulated field.
Working knowledge of ISO 13485:
2016 or equivalent.
Knowledge of 21 CFR 820, or 21 CFR 210, 211 and Part 11, a plus.
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