Senior Quality Assurance Engineer Lead
6 hours ago
We are seeking an experienced Senior Quality Assurance Engineer Lead to join our team at Novartis Group Companies. As a key member of our quality assurance organization, you will be responsible for providing support to the QA Operations organization for the review and approval of technical QA records.
The successful candidate will have a strong background in validation, maintenance, engineering, or technical quality in a pharmaceutical cGMP or medical device environment. They will be knowledgeable of cGMP procedures and have excellent collaboration and communication skills.
The Senior Quality Assurance Engineer Lead will act as the main contact for technical QA related support for the site, including acting as SME for change controls, reviewing technical QA documents, supporting deviation investigations and CAPA's from a quality perspective, etc. In this role, you will also be a key player for future site expansions.
Key Responsibilities:- Provide support to the QA Operations organization for the review and approval of technical QA records.
- Act as the main contact for technical QA related support for the site.
- Act as SME for change controls, reviewing technical QA documents, supporting deviation investigations and CAPA's from a quality perspective, etc.
- Support the creation and review of source documentation intended to be used for regulatory submission.
- Support the preparation and execution of pre-approval inspection by FDA or any other health authority.
- Support further expansion of the site with additional manufacturing lines including establishment, review and approval of maintenance and calibration strategy, validation and maintenance protocols, reports and records for the production, warehouse/supply chain and QC departments.
- Act as single point of contact for QA validation/calibration and maintenance during audits and inspections.
- Perform QA oversight for validation and qualification activities for specific manufacturing and QC studies.
- Act as QA investigator to review deviations or OOx related to validation, maintenance, calibration, and technical production related issues.
- Bachelor's degree in a scientific area. Advanced degree preferred.
- 5 years of experience in validation, maintenance, engineering or technical quality in a pharmaceutical cGMP or medical device environment.
- Knowledge of cGMP procedures.
- Excellent collaboration and communication skills.
- Very good administrative skills and working knowledge of MS365 and Adobe Acrobat.
We offer a competitive salary range of $112,800 to $169,200 per year, as well as a comprehensive benefits package, including medical, financial, and other benefits. We are an equal opportunity employer and welcome applications from diverse candidates.
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