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Validation QA - HVAC/Isolator
Eingestellt von Harvey Nash IT Recruitment Belgium
Gesuchte Skills: Support, Engineering
Projektbeschreibung
QA Validation Expert HVAC/Isolator
Task Description
* He/She ensures the QA oversight of the continuous validation activities
* To take part in the establishment, the implementation, the follow-up and the maintenance of the continuous validation plan (CVP),
* To define the validation strategies through the change control process (RPC),
* To write and implement some validation documentation (VP, VSR, Risk Assessment, Gap Analysis),
* To review and approve specific qualification and validation documentation (IQ, OQ, PQ, PV),
* To ensure the correct application of the validation quality systems on the field and to define improvement plan as required,
* To support the production & technical services teams in the implementation of the validation activities,
* To ensure the adequate management of validation deviation (QA GMP Responsible) and potentials CAPA (Compliance Authority).
Primary Tasks & Responsibilities
* Manage QA activities related to one or more Quality systems (ie Deviations, CAPAs, Batch, Release, Environmental Monitoring, Change Control, etc)
* Manages relationship with operations
* Maintains and trains SOPs, as required
* Perform gap analysis, system effectiveness reviews and other management reviews, as required
* Challenge, review and approve qualification and validation (IQ, OQ, PQ, PV) documentation and ensure they are written in accordance with the company's standards and procedures.
* Write some validation (VP, PQ, PV, VSR, PVMP) documentation according to the company
* standards and procedures.
* Ensure adequate oversight and follow-up on the validation deviations both in terms of content (root cause and CAPA).
* Support from a compliance point of view the MPU Product & Process, Production and QA Operations for validation topics. Build a strong partnership with these key stakeholders.
* Support the validation approach and decision during internal and external inspection
* Ensure implementation of validation related commitments towards internal and external authorities and organize the follow-up
Required Experience & Knowledge
* Validation practices
* Aseptic practices
* cGMP
* Good validation practices knowledge
* 4 Years of experience in validation including QA responsibilities
Soft Skills
* Good interpersonal relationship skills
* Good oral and written communication skills in French & English
* Problem solving and achievement oriented
Education
University degree (Biotechnology, Agronomy, Chemistry, Engineering or Pharmacy)
Other
SAP, MS Office
Languages
English Business
French Fluent
Task Description
* He/She ensures the QA oversight of the continuous validation activities
* To take part in the establishment, the implementation, the follow-up and the maintenance of the continuous validation plan (CVP),
* To define the validation strategies through the change control process (RPC),
* To write and implement some validation documentation (VP, VSR, Risk Assessment, Gap Analysis),
* To review and approve specific qualification and validation documentation (IQ, OQ, PQ, PV),
* To ensure the correct application of the validation quality systems on the field and to define improvement plan as required,
* To support the production & technical services teams in the implementation of the validation activities,
* To ensure the adequate management of validation deviation (QA GMP Responsible) and potentials CAPA (Compliance Authority).
Primary Tasks & Responsibilities
* Manage QA activities related to one or more Quality systems (ie Deviations, CAPAs, Batch, Release, Environmental Monitoring, Change Control, etc)
* Manages relationship with operations
* Maintains and trains SOPs, as required
* Perform gap analysis, system effectiveness reviews and other management reviews, as required
* Challenge, review and approve qualification and validation (IQ, OQ, PQ, PV) documentation and ensure they are written in accordance with the company's standards and procedures.
* Write some validation (VP, PQ, PV, VSR, PVMP) documentation according to the company
* standards and procedures.
* Ensure adequate oversight and follow-up on the validation deviations both in terms of content (root cause and CAPA).
* Support from a compliance point of view the MPU Product & Process, Production and QA Operations for validation topics. Build a strong partnership with these key stakeholders.
* Support the validation approach and decision during internal and external inspection
* Ensure implementation of validation related commitments towards internal and external authorities and organize the follow-up
Required Experience & Knowledge
* Validation practices
* Aseptic practices
* cGMP
* Good validation practices knowledge
* 4 Years of experience in validation including QA responsibilities
Soft Skills
* Good interpersonal relationship skills
* Good oral and written communication skills in French & English
* Problem solving and achievement oriented
Education
University degree (Biotechnology, Agronomy, Chemistry, Engineering or Pharmacy)
Other
SAP, MS Office
Languages
English Business
French Fluent
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Ingenieurwesen/Technik, Sonstiges