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Validation Analyst

Job in Borehamwood - England - UK , WD6 1
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Company: Marketplace Technical
Full Time position
Listed on 2020-09-30
Job specializations:
  • Pharmaceutical
    Pharmaceutical QA, Validation Engineer
  • Research/Development
    Laboratory Analysis
Job Description & How to Apply Below

International Pharmaceutical Manufacturer seeks an experienced Method Validation Analyst.

About the role:

  • To contribute to the Quality Laboratory function at by managing approved projects
  • Validate methods and equipment,
  • establish new and modified analytical methods in the Control Laboratory
  • provide analytical support for troubleshooting and non-routine test methods.

Duties may include:

  • To perform a wide variety of method and equipment validation activities in accordance with Standard Operating Procedures, protocols, policies and GMP.
  • Responsible for preparing reagents, standards and control samples in support of validation work.
  • To promptly report any validation deviations, out-of-specification / limits results.
  • Raise in the quality system and complete Phase I investigations
  • Raise validation deviations in the quality system, leading minor investigations and ensuring effective implementation of identified CAPAs. Support major validation deviations.
  • Support controlled changes within the department
  • To read, collate, report, analyse and archive validation data using defined documentation and computer systems.
  • To ensure equipment used is clean, calibrated and maintained. Perform system suitability checks where required
  • To assist with the calibration or validation of laboratory equipment and automated systems.
  • Ensure required stock available for validation work, ordering quantities required in advance of initiation of work.
  • Preparation of validation life cycle documentation
  • To operate a variety of instrumentation and computer software packages intended for data analysis, collation and other related applications (e.g. Minitab).
  • To make recommendations and perform updates of departmental documentation (e.g. SOPs).
  • Undertaking administrative activities.
  • To organise own assigned working activities. To be responsible for reporting issues or delays to next line management.
  • Perform training of Level I + II Analysts
  • To identify continuous improvement initiatives.
  • To attend meetings as required.
  • Perform review of basic laboratory documentation
  • To participate in the receipt of audits from internal and external sources, ensuring own work area is audit ready at all times.
  • To adhere to record and data integrity requirements, as per polices.
  • To perform any other aspects of laboratory testing and support the objectives of the department as required.
  • Responsible for ensuring own training record is completed and up to date

Skills and experience:

  • Degree in a relevant scientific discipline and experience working in the pharmaceutical industry (or equivalent)
  • Experience of working in a laboratory environment
  • Understanding of GMP/GLP.
  • Good knowledge of the pharmaceutical industry, both within a laboratory and across pharmaceutical processes.
  • Understanding and knowledge of Validation of both Methods and Equipment
  • Knowledge of laboratory SOPs and ability to revise and write new procedures......
Position Requirements
Less than 1 Year work experience
Note that applications are not being accepted from your jurisdiction for this job currently via this jobsite. Candidate preferences are the decision of the Employer or Recruiting Agent, and are controlled by them alone.
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