Key Responsibilities
- Preparation and implementation of SOPs, STPs, formats, and records for injectable operations including cartridge / PFS and isolator-based filling lines.
- Execution of document control activities including issuance, revision, and archival.
- Initiation and tracking of change controls related to facility, equipment, utilities, and documentation.
- Support deviation documentation and investigations during commissioning and qualification phases. - Support CAPA implementation and tracking.
- Cross-functional coordination with QA, QC, Engineering, Validation, and Projects teams.
Education: B.Pharm / M.Pharm / B.Sc / M.Sc
Experience: 7–8 years in Injectable / Sterile Operations QMS
Preferred Exposure: Cartridge / PFS manufacturing and isolator-based aseptic filling lines
Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.
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 drugsafety@amneal.com. If you are currently experiencing a life-threatening event, please immediately contact 911.
