Medical/Pharmaceutical/Scientific

Pharmaceutical Process Expert

Full Time Permanent

The Recruitment co are currently recruiting for a Pharmaceutical Process Expert to work for our client based on the Wrexham Industrial Estate on a Permanent basis.

Monday to Friday – 8am to 4pm
Some flexibility will be required plus some weekend working but with paid overtime.

Salary dependant on experience. Main responsibilities.

Learn the 'end to end' LANT process and be able to support with developing the process in readiness for GMP transfer

Develop documentation to support manufacture of LANT in a GMP environment.

Lead problem solving initiatives for manufacturing investigations within LANT processes and regulatory standards.

Participate in process development, monitoring and data gathering to drive analysis and improvements

To lead and deliver Continuous Improvement activity in support of the objective to deliver a compliant GMP process which can manufacture LANT to regulatory and local requirements.

To train BAS team members in the LANT process to ensure GMP batches can be made in a safe and compliant manner

Review, Edit and preparation of SOPs for LANT processes

Input/manage manufacturing data to support LANT process validation and continuous process validation

Creation and review of protocols and reports

To use SAP for purchase of new equipment/ replacement of items, raising of work requests, checking of manufacturing schedules.

To be the expert in LANT processes and methods and to use this expertise to drive the transfer through to GMP manufacture.
Qualifications

Graduate in an appropriate discipline

Lean Six Sigma Qualification

Scientific, Quality or Biological manufacturing background.

Experience of GMP production,

competent in GDP
Experience:

Ensure regulatory and procedural (local) compliance

Experience with Trackwise, Change controls

Proficient in writing GMP documentation
Key Technical Competencies Required
IOSHH or NEBOSSH certification desirable.

Be comfortable working as part of a cross functional team with different stakeholders of different levels.

Leads with purpose and direction

Operational Excellence: Incorporate operational excellence into normal ways of working.

Demonstrate understanding of Lean Six Sigma (LSS) principles and commitment to successful implementation of LANT tech transfer project using LSS Methodology.

The Recruitment co is an equal opportunities employer.

CPChesterThe Recruitment Co. is an equal opportunities employer and we're committed to diversity and inclusion in the workplace

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