Quality - Quality Assurance Scientist

Weil Group, Inc Manatí, PR , PR 33872

Posted 4 days ago

MAJOR DUTIES AND RESPONSIBILITIES:

  1. Supports manufacturing operations areas (OSD and Parenteral product) such as Compounding, Filling, preparation, capping, Inspection, compression and packaging to assure that appropriate cGMPs are in place through frequent operations audit.
  2. Manages audit observations, investigations and CAPAs records in Trackwise on timely manner and participates in the investigations management process to identify root cause, evaluate and approves Corrective and Preventive actions (CAPAs).and provides appropriate recommendations for the lot disposition.
  3. Reviews and approves the investigations occurred in the manufacturing process (OSD and Parenteral products), facility and utilities, microbiology and warehouse areas.
  4. Reviews and approves the master documentation related to manufacturing and support areas such as CRs, SOPs, WPPs, BOMs, qualification and validation Protocols with government regulations and Client Policies.
  5. Provides technical guidance and compliance support in the transfer of new products and process to maintain quality standards.
  6. Manages audit observations, investigations and CAPAs records in Trackwise on timely manner.
  7. Maintains management informed (via frequent written reports) of any problem that might affect the quality and/or timely release of materials.
  8. Assures that electronic systems (PMS, Syncade, Maximo, Quasar etc) are aligned and in compliance with cGMPs, Regulatory Standards and requirements for domestic and international markets.
  9. Provides support and training to other departments as required.
  10. Participates in the risk analysis process when a quality event has happened that cannot be solved immediately and assesses the needs to be completed to continue or prior to resumption of manufacturing process.
  11. Keeps track of the Department performance and attainment to deadlines and goals by means of the QC/QA Metric System.
  12. Performs product Acceptance Quality Level (AQL) during inspection (parenteral products) stage and distribute reserve and/or stability samples to the appropriate area.
  13. Supports Media Fill activities in order to assure that typical and atypical interventions are performed as established.
  14. Reviews and approves the instrumentation and equipment Calibration records and engineering drawings ensuring there are effective systems for the maintenance and calibration of critical equipment and, approves calibration requests..
  15. Participates in PAT, department staff and planning meetings as required.
  16. Reviews and approves equipment, utilities and facilities qualification and system life cycle documentation.
  17. Reviews and approves all executed batch production records and laboratory testing records before release of the product for distribution to assure that no deviations have occurred, or if deviations have occurred, that they have been fully investigated.
  18. Reviews and approves all process, product and computer systems validation protocols and reports, change control documentation, redressing / reprocessing / rework operations, investigation reports related to manufacturing process and microbiology laboratory, and Annual Product Quality Review (APQRs) elements.
  19. Supports the resolution of product and process issues associated to Quality Events.
  20. Reviews supporting data for compliance with cGMP documentation practices.
  21. Approves or reject procedures and specifications impacting drug products, raw material or packaging components.
  22. Verifies compliance with Client Policies and Guidelines.
  23. Participates as quality representative or liaison in site projects
  24. Assures that the manufacturing and packaging procedures are properly followed and adequate for their use.
  25. Verifies consistency with other site procedures and/or specifications. .
  26. Ensures the designation and monitoring of storage conditions for quarantine materials and products.

KNOWLEDGE / SKILL:

  • Bachelor Degree in Science, Chemical Engineering, Biology, Pharmacy or Microbiology.

  • 3 years of experience in the pharmaceutical industry.

  • Minimum 1 year of experience in Quality Assurance responsibilities in a pharmaceutical industry.

  • Knowledge of manufacturing operations of Solid Dosage and Parenteral Products Manufacturing.

  • Strong knowledge of relevant GMP, FDA, EU regulations and the ability to interpret and apply them for intended use.

  • Fully bilingual (Spanish/English) communication skills, both written and verbal are required.

  • Self-motivated, creative and team work oriented.

  • Excellent interpersonal skills and the ability to interact with people at all levels.

  • Proficient knowledge of computer systems (Microsoft Office, etc.) and applications like Trackwise and SAP.

  • Solid ability for analyzing data detecting deviations, inconsistencies and interpret sampling test results.

  • Knowledge of problem solving and root cause analysis methodologies (i.e. Kepner Tregoe)

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Quality - Quality Assurance Scientist

Weil Group, Inc