Piramal Enterprises Ltd

QC QUALITY & COMPLIANCE SPECIALIST (BB-37D5A)

Found in: Neuvoo CA

Description:

Job Description

Description

Quality and Compliance Specialist – Quality Control

Provide assurance that all data generated from the analytical laboratories are accurate, complete and in compliance with data integrity, current Good Manufacturing Practices (CGMP), clients and regulatory agency requirements. Maintains quality and compliance by identifying quality requirements, disseminating standards, policies, and procedures and recommending improvement plans.

JOB RESPONSIBILITIES:

  • Review all analytical data generated by the analytical laboratories including but not limited to raw and packaging materials, product contact materials, in-process controls, cleaning verifications, products, method validations, method transfers, stability studies, standard qualifications, batch release, R&D samples (as applicable) and any third party samples for accuracy, completeness and compliance to data integrity, written procedures and CGMP regulations
  • Review all planned and unplanned deviations for accuracy, completeness and compliance to data integrity, written procedures and CGMP regulations
  • Release of starting materials (raw materials, packaging and product contact materials) for GMP manufacturing
  • TIMS release of all tests and samples listed above
  • Issue deviations numbers, as applicable
  • Review lab equipment and instrumentation Calibration and Preventive Maintenance (PM) Reports
  • Ensure compliance with internal approved procedures, specifications and protocols of all generated data
  • Ensure timely completion of all data review
  • Filing of request forms, runlogs, lab numbers and other lab documentation, as required
  • Review out-of-specifications, analytical deviations, investigations and run log summaries
  • Maintain accurate impurity profiles for all manufactured batches including intermediates and finished products
  • Perform initial review of research and pilot specifications versus raw data from method development, representative R&D samples and first batch introductions and inform the QC Manager of any required changes to specifications
  • Create and revise Certificates of Analysis and other technical documents as required
  • Revise via change control documentation as required
  • Participate in the implementation of continuous improvement initiatives as they relate to quality activities (e.g., introduction of new technology and automation with respect to data acquisition, electronic review, quality management systems, LIMS, etc.)
  • Participate in internal and external audits
  • Provide data and information pertaining to lab or systems for internal or external clients as requested
  • Perform other related assignments and projects as required
  • calendar_today6 days ago

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    location_on Aurora, Canada

    work Piramal Enterprises Ltd

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