Validation Team Lead
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|Location:||Waterford, Wexford, Tipperary|
Our client, a pharmaceutical company are looking for a Data Reviewer to join their team. This is an opportunity to join an established company in a challenging and rewarding role with excellent opportunities for personal development.
- Comply at all times with the Health, Safety and Environmental policy and associated procedures.
- Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do.
- Ensure all work carried out, is in compliance with the required standards, conforming to company, cGMP, cGLP, SOP’s and regulatory guidelines.
- Take ownership for quality compliance in all activities you are responsible for.
- Ensuring approaches are aligned with current guidelines (ICH/ASTM etc).
- Integrating as far as possible Engineering activity and validation activity.
- Developing procedures and processes which ensure Validation activity is integrated into process design and Engineering execution in new projects and processes.
- Develop the site validation schedule and ensure it is scalable in the event of future additions.
- Develop validation protocols as required ensuring at all times that acceptance criteria is clear and related to process capability.
- Ensure the site change control procedure is integrated into documentation and procedures.
- Manage internal and if necessary external outsourced routine requalification of process equipment.
- Represent the validation strategy and validation results in audits as required.
- Benchmark other industries and organizations to ensure best practice is in use.
- Be active in the network, attending conferences/training seminars as needed.
- Qualified to a minimum of Degree level in engineering or related discipline.
- Minimum 5 year’s Validation Engineering experience within a relevant Pharma. environment.
- Proven track record in the industry in process validation and the development of procedures and processes to support best practice.
- Ability to understand engineering processes through a logical, data driven, hands on approach.
- Understanding of current validation best practice.
- Knowledge of sterile Manufacturing and validation techniques.
- Experience in Cycle development and validation for sterile manufacturing.
- Use of FMEA, FMECA and Risk assessment techniques.
- Familiar with statistical process control methods.
- Can interact with audits (internal and external)
- Proven track record of building relations with equipment vendors.
- Excellent report writing skills.
- cGMP compliance.
Hartley People Recruitment work to the highest ethical standards within our industry and we value the trust that you place in us when you send your CV. We can provide a full consultation in confidence and we guarantee that your CV will not be sent to any of our clients without your prior consent.
For immediate consideration please call Pairic on 051-878813 or email your CV in response to this job posting.
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