Sr. QA Validation Specialist | Limburg | 6-Month Contract

Sr. QA Validation Specialist

Location: Geleen, Limburg
Startdate: As soon as possible
Contract: 6 months (40 hours a week)

Job Description Summary

Sr. Validation Specialist reviews and approves documentation and oversees qualification and validation deliverables, associated with equipment, facility and utilities. He/she reviews and approves validation documents and procedures associated with equipment, facility and utility operation, cleaning and maintenance. He/she assures the deviations and changes are well documented and applicable corrective actions and systemic solutions are applied.

Job Description

Main responsibilities are:
* Overseeing validation and qualification deliverables:
* Review and approve URSs;
* Review and approve qualification and validation plans;
* Review and approve validation documentation associated with equipment, facilities and utilities (DQ, IQ, OQ, PQ);
* Review and approve the risk assessment related to equipment, facilities and utilities;
* Review and approve the commissioning protocols and reports;
* Review and approve FAT/SAT documentation;
* Assure requirements traceability throughout the whole project validation file (from URS to PQ).

* Overseeing validation life cycle documentation:
* Review and approve equipment, facility and utility life cycle documents;
* Ensure the correct application of the validation quality systems on the field and to define improvement plan;
* Understanding of cGMPs, GAMP, ICH Q7A and validation practices (IQ/OQ/PQ) and their application in practice.

* Conducting periodic review of validated GxP equipment, facility and utilities.
* Performing validation impact assessments prior to implementation of changes on equipment, facility or utilities.
* Provide support in all quality-related issues, including GMP regulations, compliance with internal SOPs and all aspects of safe, reliable and consistent operation of the system.

* Support the production & technical services teams in the implementation of the validation activities.
* Ensure the adequate management of validation deviations (be QA GMP Responsible) and potentials CAPA (be Compliance Authority).
* Manage deviations and changes in order to ensure that these are well documented and that corrective actions are taken and followed-up upon.
* Contribute to continuous improvement and International standardization for topics related to equipment, utilities and facilities.

Qualifications
Degree - Technical diploma / bachelor of science / master of science
Field of Study - Engineering, Biology / Biomedical science, Life Science, or other job related discipline
Work Experience - Advanced - 5-10 years

Responsibilities
Quality
* Complies with Good Manufacturing Practices guidelines in all activities.
* Experienced with Quality Management and GxP Regulations
* Knowledge of Validation Methodologies
* Knowledge of Quality Systems, European and FDA regulations, cGMP, GDP
* Knowledge of the manufacturing processes
* Requires excellent analytical skills with systematic approaches to problem solving. Must be able to break down complex problems and tasks into activities capable of being performed by personnel.
* Sound industry knowledge, project proficiency, and autonomy expected.


Skills What analytical capabilities or niche skillset does this role require?
* Strong written and oral communication skills.
* Strong organizational and time management skills to carry out multiple assignments

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