About this role
- Develops and implements visual inspection procedures, including SOPs and work instructions, for manual, semi-automatic, or fully automatic systems inline with SOP/ Regulatory requirements.
- Ensure Visual inspection is being performed as per respective SOP.
- To ensure availability of sufficient VI inspector as per process requirements.
- Good hands-on KNAPP kit preparation & qualification activity.
- Ensures all products adhere to quality, safety, and regulatory standards (e.g., FDA, EMA, ICH).
- Hires, trains, and manages inspectors, ensuring high-performing, compliant, and motivated staff.
- Monitors inspection processes, analyses data for trends, and initiates corrective actions (CAPA) or process improvements.
- Collaborates with Engineering to validate equipment and maintain inspection limits.
- Collaborates with SCM, MFg. to plan VI activity to meet business requirements.
- Prepare & Reviews batch records, deviation reports, and face internal/regulatory audits.
- Compliance of audit observations.
Skills Required:
- Good Manufacturing Practice (GMP)- Expert
- Regulatory Compliance- Expert
- SOP and Document Review & Approval - Expert
- Handling of packing and visual operations- Expert
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
- Develops and implements visual inspection procedures and ensures compliance with quality and regulatory standards. Hires, trains, and manages inspectors while monitoring inspection processes and initiating corrective actions.
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