About this role
Job Responsibility
- To monitor scale up batches, exhibit batches, pre-validation batches & validation batches as per approved plan, and check/review/approve related documents.
- To co-ordinate for procurement of tooling, RM code creation, RM indent for site transfer projects & new products.
- To execute exhibit batches with alternate API source.
- To execute & monitor activity related to product site transfer projects & relevant documentation.
- To monitor critical process parameters of process validation batches of new/existing products & related documentation, ensuring successful launch of new products.
- To review batch manufacturing records (proposed & commercial), process study protocols & reports, trial batch protocols & reports.
- To review stability protocols, validation protocol, change controls, deviation, CAPA, investigations & other relevant documents.
- To support documentation, process validation, troubleshooting, process improvement & cycle time reduction activities in scale up, exhibit & validation batches.
Skills:
- Expertise in monitoring scale-up, exhibit, and validation batches.
- Strong in reviewing BMRs, protocols, reports, stability studies, deviations, CAPA, and change controls.
- Effective coordination with R&D, QA/QC, Regulatory, and Manufacturing teams.
- Hands-on problem solving, process improvement, and cycle time reduction.
- Strong understanding of regulatory guidelines for OSD
Other facts
About Amneal
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.
What you'll do
- The manager will monitor and execute scale-up, exhibit, and validation batches while ensuring compliance with approved plans and documentation. They will also coordinate procurement and support process validation and troubleshooting activities.
Ready to join Amneal?
Take the next step in your career journey