QC EQUIPTMENT OFFICER - UP TO £27K - WILTSHIRE

Posted 13 September by Bosch Global Associates Ltd

JOB SUMMARY

Support the equipment used in the QC Section. Ensure equipment is and stays correctly specified, validated and calibrated for use in a GMP regulated environment. Provide hands on assistance during validation exercises carried out by the Validation department.

MAIN DUTIES AND RESPONSIBILITIES

  • Specify new QC equipment and ensure current equipment remains suitably specified in collaboration with users
  • Ensure that equipment is appropriately validated and calibrated for GMP use in collaboration with the Validation department.
  • Write procedures for new equipment and update procedures for current equipment as necessary.
  • Provide hands on assistance to the Validation team ensuring that equipment validation is carried out in a suitable time frame.
  • Interact with equipment suppliers to keep equipment up to date, ensure that equipment stays compliant, ensure PBL has the most suitable equipment and ensure repairs when necessary are made suitably.
  • Assist with the evaluation of potential new equipment.
  • Keep GMP records of equipment up to date.
  • Ensure equipment within QC is consistently audit ready.
  • Assist with the safety assessments for QC equipment.
  • Produce and review GMP documentation as required for example SOPs, Protocols and Reports
  • Carry out training of QC staff in the use of new equipment.
  • Maintain an up-to-date awareness of regulatory and scientific developments via courses, meetings and literature.

REQUIREMENTS

  • Degree in Biological Science or Chemistry or Biochemistry

KNOWLEDGE AND EXPERIENCE

  • Good working knowledge and experience of cGMP
  • Good working knowledge and experience of Analytical and QC equipment
  • Good understanding of 21 CFR part 11 compliance associated with QC equipment
  • A clear understanding of data integrity
  • Knowledge of and practical experience in the specifying of QC equipment
  • Knowledge of and practical experience in validating QC equipment
  • Knowledge of and experience in troubleshooting problems with QC equipment

SKILLS AND CAPABILITIES

  • Ability to use technical software packages
  • Able to logically troubleshoot and discuss data with engineers
  • Able to apply theoretical knowledge to practical situations

KEYWORDS

PORTON DOWN / WILTSHIRE / SALISBURY / BIOLOGICAL SCIENCE / CHEMISTRY / PHARMACEUTICAL / DEVELOPMENT / ANALYTICAL / EQUIPMENT / PHARMACEUTICAL PRODUCTION / PROCESS DEVELOPMENT / ANALYTICAL DEVELOPMENT / QUALITY CONTROL / QUALITY ASSURANCE / GMP / SUPERVISOR / TECHNICAL FILES / TECHNICAL DOCUMENTATION / ICH GUIDELINES / SOFTWARE / cGMPs / METHODS / ESSAYS / TECHNIQUES / SYSTEMS / CONSUMABLES / IDENTIFYING / EVALUATING / ADAPTING / TECHNOLOGIES / PBL / IDENTIFYING / ADAPTING

Reference: 31783137

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