Commissioning and Qualification Specialist

Job type:
Start date:
Quanta Consultancy Services
Republic of Ireland
Published at:
flag_no United Kingdom
Contact person:
Lee Mitchell
Project ID:

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C&Q specialist required to join a pharmaceutical company in central Ireland. The Commissioning and Qualification Engineer will be responsible for supporting a number of PV batches for an initial 3 month contract.

Role and responsibilities:

* Strong experience in the facility and GMP utility commissioning and qualification

* Strong experience in qualifying manufacturing process automation systems

* Strong experience in equipment commissioning qualification

* Experience and participation in HPRA/ IMB audits

* Experience operating in a Manufacturing or Operations environment

* Understanding of Pharmaceutical Manufacturing Processes

* Strong experience and working acknowledge of quality systems including Deviation and CAPA generation, investigation and resolution

* Ability to assess impact of changes to direct and indirect systems during commissioning activities

* Ability to co-ordinate and lead commissioning and qualification activities against project schedule and report to the validation lead and head of quality

* Ability to resolve validation and qualification exceptions/deviations

* Ability to liaise with cross functional teams and other contracting resources

* Ability to direct and articulate quality requirements and represent the client in the achievement of compliant and qualified systems.

* Strong communication skills 

If this is you please apply today.