About this role
Essential Functions:
- Preparation of SOPs, Specifications, and method of analysis (Raw material, In-Process and Finished product)
- Review of DMF to prepare Analytical method and specification
- Initiate Change Control and Deviation.
- Good understanding for Impurity profiling
- Well versed with regulatory agency's current requirement.
- Well versed with ICH quality guidelines
- Good knowledge for Pharmacopoeia
- Good communication especially writing skills for preparing quality documents and coordination with Cross functional teams.
Skills:
- Quality based Regulatory Submission Documentation - Advanced
- Document Review & Evaluation as quality and regulatory standard - Intermediate
- CAPA (Corrective and Preventive Actions) Documentation - Advanced
- Cross-Departmental Coordination - Advanced
- Change Control Documentation - Advanced
- Good Documentation Practices (GDP) - Intermediate
- Laboratory Information Management System (LIMS) - Advanced
- open to feedback and coaching - Advanced
Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.
Key roles that the Human Resources team performs:
Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.
Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.
Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.
Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance.
Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.
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 role involves the preparation of SOPs, specifications, and analytical methods for various products. It also includes reviewing DMFs and initiating change controls and deviations.
Ready to join Amneal?
Take the next step in your career journey