QA VALIDATION ENGINEER

QA VALIDATION ENGINEER2018-09-18T15:51:17+00:00

QA VALIDATION ENGINEER

TARGET START DATE:                      October/ November 2018

LENGTH OF ASSIGNMENT:            12 months +

LOCATION:                                          Grand Bahama.

BACKGROUND

As a member of the Quality organisation, the QA Validation Engineer is responsible for ensuring that all qualification and validation activities conducted by the client or approved third parties, comply with Company, Quality and regulatory requirements and expectations.  This is a wonderful opportunity to be part of a start up facility project.

RESPONSIBILITIES

The QA Validation Engineer is responsible for:

  • Providing hands on support, guidance and direction to all areas of the organisation including its third-party contractors.
  • Support all Plant activities, scheduling and any other department or function within the organisation that requires support related to Qualification and validation.
  • Scheduled qualification and validation activities as part of process / facility changes / improvements, deviations, customer and regulatory inspections etc.
  • Assisting with the development of validation documentation (plans, protocols, reports etc.)
  • Facilitating and performing supporting activities as required:
    • Generation and review/approval of deviations.
    • CAPAs, change requests & SOP/Work instructions.
    • Risk Assessments & System Impact Assessments.
    • Periodic key performance indicator reporting
    • Supporting documentation necessary to perform the necessary qualification or validation activities.
  • Supervisory experience for new Plant and management of third party providers
  • Plan, execute or coordinate the qualification and validation activities as required
  • Cleaning Validation and Process Performance Qualification (PPQ)/Process Validation (PV) in Plant 3, system walk-downs, environmental monitoring program etc.

 

 EXPERIENCE REQUIRED

  • 7- 10 years of hands on experience in Equipment Qualification & Process Validations
  • Pharmaceutical/ Biopharmaceutical experience under cGMP regulations
  • API experience is highly desirable
  • S. , M.S. or MBA in Science, Biology, Chemistry, or Engineering.

To find out more about this new opportunity please send your CV to info@kpc-international.com or for a confidential conversation call Barry Jones on +353 21-2363154

WE'RE HIRING