Validation Specialist - Engineering Technical Support
Edison-New Brunswick Metro Area, NJ
- Sr. Specialist, Validation & Lab Oversight
- B.S. degree required, minimum of five years of experience in the pharmaceutical or related industry.
The Sr. Specialist, Validation & Lab Oversight is responsible for providing quality oversight for Site Validation activities and Quality Control Laboratory Operations in accordance with policies, standards, procedures and Global cGMP.
- Functional responsibilities for the incumbent include ensuring accurate and timely maintenance and review of validation and qualification documents for all equipment and facility activities; providing compliance oversight for the QC laboratories; ensuring accurate and timely review of laboratory investigations; performing analysis on quality indicating data and identifying any trends noted for QC data; providing oversight for data integrity initiatives for the site.
Must have GMP, Quality, and in-depth risk management knowledge.
- Must manage development of technical or scientific initiatives and activities by interdisciplinary teams.
- Supports all activities for the Quality Operations Validation & Lab Oversight group.
Support the Qualification and Validation activities in relation to QC and manufacturing equipment and facility design.
Assures appropriateness of calibration/maintenance programs, validation plans, qualification protocols, associated reports and procedures.
Ensure compliance with the site validation master plan, assist with facility start-up operations and product transfers supporting the Qualification and Validation teams.
Review media simulation activities to ensure successful execution and documentation.
Ensure site is compliant with global and regulatory data governance and data integrity requirements.
Establishes and maintains procedures to ensure Data Integrity is maintained and procedures/processes are compliant.
Provide Quality oversight of QC Chemistry and QC Microbiology.
Work with laboratory management to ensure laboratory activities comply with global regulatory requirements.
Ensure procedures are adequate to review and confirm appropriateness of laboratory raw data.
Review/approval of laboratory deviations.
Ensure the site stability program meets global and regulatory requirements.
Ensure method qualifications, method transfers, and analyst trainings meet company and regulatory requirements.