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Role
To coordinate the development and maintenance of the company’s validation program in compliance with all applicable regulatory and company requirements. Co-ordination, implementation and active participation in the site Validation Program.
Responsibilities:
* Ensure all Computerized systems are qualified in compliance with Data Integrity policies and regulatory requirements.
* Co-ordination / direction and active participation in the validation of site equipment, facilities, utilities, processes and software in compliance with company policies, FDA,
* European cGMP and GAMP standards.
* Generation/maintenance of the Validation Master Plans.
* Generation/maintenance of Project Validation Plans.
* Generation of validation plans, protocols and final reports to cGMP standard.
* Review / approval of all protocols and final reports.
* Management of validation change control process.
* Adheres to and supports all EHS & E standards, procedures and policies
Supervision Received
* Individual is given authority to carry out their duties without close supervision.
* Reports to Validation Team Leader.
* Goals are reviewed on a regular basis and formal performance reviews are carried out once per year.
Supervision Provided
* No direct reports.
* Provide guidance to functional areas the area of Validation.
* May provide cross training and guidance to new department members.
Qualifications:
* 3rd level qualification in a relevant engineering or scientific discipline.
Job/Technical Skills
* A minimum of 5-10 years’ experience in a cGMP regulated environment.
* A good understanding of regulatory requirements.
Ownership and Accountability
* The position has a high level of autonomy and individuals are expected to work on their own initiative.
* Adheres to and follows all procedures policies and guidelines ensuring compliance with cGMP and HPRA/FDA regulations and company policies, procedures and guidelines.
* Individual is fully responsible for the co-ordination and closure of projects assigned.
* This position is crucial in identifying systems requiring validation and ensuring that this activity is documented, actioned and resolved.
* This position impacts on product quality and technical performance as well as manufacturing operations.
* Requires an ethos of Right First Time at all times.
Decision Making/Impact
* Expected to provide functional expertise to support daily operations.
* Seeks Managers input when making decisions which affect the area.
* Is a site SME on validation issues and provides guidance on same.
* Decision making within confines of agreed responsibility with Team Leader.
For immediate consideration please forward your CV to
Pro Contract Jobs
Sterling House,
East Wing, Suit 310E,
Langston Road,
Loughton, IG10 3TS.
Phone No: 0203 371 1252
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