Commissioning And Qualification Specialist

Job type:
Quanta Consultancy Services
flag_no Ireland
project ID:

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This global client is looking for a C&Q specialist with core experience in commissioning, qualification and validation to support API and Lab qualification activities. This role will be part of a multidisciplinary team providing technical support to the API process.

Key responsibilities:
* Commission and Qualify (C&Q) various process and laboratory equipment.
* Design and execute process validation studies for the large Scale API processes.
* Review and assess change control for API processes to determine impact on validated state.
* Apply Lean Six Sigma and Lean methodologies, with an understanding of regulatory and validation requirements.
* Participate in efficiency and streamlining projects contribute to process improvement, technology transfer, new product introduction and other projects.
* Lead and Participate in cross-functional problem solving teams for troubleshooting, and investigations.
* Prepare, review and approval of technical documents, procedures, CAPAs, change control, deviations, metrics, etc.
* Adhere to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups. Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits and incident investigations.

Key Skills and Experience
* Strong experience in commissioning and qualification of Process and Lab equipment (stand alone and automated), cleaning and process validation
* Proven ability to deliver projects safely, Quality Compliant and on time and on budget.
* Demonstrated ability to fully realize improvement initiatives and demonstrated successes in a team environment, such as project teams, Lean Six Sigma team etc.
* Stakeholder management
* Self-motivated and ability to work as part of a team with good project management skills
* High level written and verbal communications with advanced PC skills

For more information for this fantastic opportunity please forward your CV today.