Process & Cleaning Validation Specialist, Technical Services
About this role
Description:
Process Engineer reports to the Manager of Technical Services and plans, executes and functionally directs Process/Cleaning Validation/Study assignments and projects, which require sound pharmaceutical/engineering skills and independent judgment. Works as a team member, educates internal partners on the projects, monitors and executes. Maintains effective and cooperative relationships with all departments within and outside the organization. Managing the post approval projects.
Essential Functions:
- Prepare validation protocols & reports for manufacturing process and cleaning process qualification, data analysisand prepare reports; execute the manufacturing process and cleaning process qualification/validation/study.
- Managing the post approval projects. coordinating with cross functional Teams and ensuring the timely completion of projects.
- Analyzes statistical data, products or functional specifications to determine conformance with standards andestablished quality requirements
- Coordinate/oversee the development of new processes or troubleshoot existing ones
- Assist in deviation/investigations to identify root causes and define corrective and/or preventative actions (CAPA) & assist in various audits
Additional Responsibilities:
- Initiation of Change Controls and Planned Deviations when required
Company at a glance
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver.
Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions.
Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam.
Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.
Top Benefits
- Health insurance
- Insurance benefits
- 401(k) matching contribution
- Employee well-being programs
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