Company Name: Actavis, Inc. Import
Job Details
Duration: Permanent
Min Education: Not Specified
Salary: Commensurate
Job Type: Full Time
Min Experience: Not Specified
Required Travel:
Location:
  • USA - Elizabeth New Jersey, 07201
Job Description
Description

The QAIG Investigator (Laboratory Systems Support) is responsible for the general oversight of Laboratory Deviations & CAPAs, Customer Complaints, Equipment/Utilities Qualifications (post execution), and Documentation Change Request/Revision (Protocols, SOPs, Lists, Forms, APR attachments, etc). * Support Laboratory area management concerning potential deviations and customer complaints. Review incidents/discrepancies/complaints and evaluate need for deviation initiation. Review, revise, and author deviation investigation reports and interim reports associated with lab deviations and complaints, ensuring compliance with cGMP's, SOP's, and FDA guidelines and requirements. Provide oversight / development for Customer Product Complaints (processing to completion). * Ensure comprehensive deviation root cause analysis and quality impact assessment. Evaluate impact and recommend disposition of product/batches involved. Provide concurrence and implement appropriate corrective and preventative actions to prevent similar occurrences. Serve as member of the Material Review Board (MRB) and chair the MRB when required. Ensure accurate reporting of site metrics related to deviations, complaints, CAPAs, etc. * Review and approve laboratory equipment/utilities qualifications (post execution) in accordance with the Validation Project Plan. Provide post execution approval as necessary for all associated documentation: Commissioning, Factory Acceptance Test (FAT), Site Acceptance Test (SAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Final Summary Reports. Review, approve, and resolve any associated observations or deviations. * Review and approve laboratory Document Change Requests affecting Protocols (sampling/testing/inspection/etc.), SOPs, Lists, Forms, etc. Maintain department SOPs consistent with site and industry standards. * Provide support during FDA site inspections. Support IT related system-based applications for Trackwise as it relates to job function. Support Supply Chain and QA Batch Release departments to ensure timely release of batches impacted by deviations to support customer service objectives. * Assess departmental needs, identify opportunities for improvement, and implement. Qualifications

* 3 to 5 years experience in Quality Assurance and/or Pharmaceutical industry (Solid Oral Dose) * Strong written and oral communication skills * Strong technical writing ability * Excellent organizational and time management skills * Ability to evaluate and set priorities according to business needs * Strong knowledge in database use and use of Trackwise for investigations * Excellent communications skills needed to facilitate relationships with cross-functional departments. * Knowledge of Quality Assurance and Quality Control requirements/applicationsEducation

BS/BA preferred in Science or related field