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Collins McNicholas

Role Responsibilities:

Product Support:

  • Creation or update of SOP required for the manufacturing of a product
  • Investigation of the events that may have an impact on product quality
  • Creation of study plans, protocols and report for product related activities
  • Support/generation of the annual product review for products
  • Generation or update of production batch records
  • Support the introduction of new products
  • Trending of process data and correction of production issues

 

Technical Support

  • Be familiar with operational flow
    • Of products
    • Of personal
    • Of waste
    • Of Information
    • Of customers and suppliers
  • Assist in the selection of the appropriate technologies to support the product manufacture
  • Support the selection process for introduction of new production equipment
  • Support/lead the process of the introduction of new equipment
  • Develop SOP to support the new equipment
  • Train the operators and other personnel in the new technologies
  • Liaise/co-ordinate/support the validation activities associated with the introduction of new equipment, process or technology
  • Be familiar with the products, the manufacturing techniques and procedures
  • Ensure Production Batch Records and SOPs are kept updated
  • Trend all manufacturing Yields

 

Meet the Quality Standards:

  • Ensure activities are executed in line in in-house procedures and in compliance with requirements of cGMP
  • Keep up to date on regulatory development and standards by accessing in house library, accessing current Pharmacopoeias etc
  • Participation in investigation into failures, out of trends and out of specifications as required ensuring follow up, following anomalies, failures and external compliance, ensuring corrective actions are implemented
  • Be familiar with GMP
  • Be familiar with and apply the procedures, instructions and rules of the industry and the plant
  • Be responsible for upholding QA rules
    • Ensure that SOP’s are applied
    • Record training for procedures
    • Notify QA about any deviation
    • Carry out corrective actions

Providing support for validation Activities:

  • Write and execute the re-qualification protocols of production/Site technology equipment
  • Write and/or review validation SOP’s for equipment, automation, cleaning and process validation
  • Prepared and/or review/or execution of process validation protocols
  • Provide support and documentation required as part of change control activities
  • Act as designee for the site technology manager
  • Interaction and support with project groups
  • Perform/assist in the performance of the Supplier Audits

 

Role Requirements:

  • Third level technical qualification to degree level desirable
  • Two or more years’ experience within a GMP manufacturing environment i.e. Pharmaceutical/Chemical/Food
  • Ability to manager both projects and own routine activities
  • Provide the necessary guidance and leadership on technical projects where required
  • Good organisational and time management skills (MS Word, MS Excel, MS Outlook)
  • Good people management skills
  • Technical competence
  • Organisational and administration skills
  • Knowledge of GMP
  • Fluent in English

 

For a confidential discussion and more information on the role, please contact Josh Barnes on 021-4911066 or email josh.barnes@collinsmcnicholas.ie

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