About this role
Essential Functions:
- To ensure that validation system remain updated as per regulatory requirements and industry standards.
- Responsible for execution and review of Qualification / Re-Qualification and Validation activity ofEquipment / System / Facility and Plant utilities.
- Responsible to co-ordinate with manufacturing, Engineering and QC personnel for respectiveQualification / Validation / Re-qualification activity for timely completion of activities.
- Responsible for preparation of Standard Operating Procedures of Quality Assurance Department.
- Responsible to conduct sampling activity as per the protocols (Process Validation, Cleaning Validationetc..).
- Responsible for preparation, review and execution of risk assessment activity related to Equipment /Process / Facility / System.
- Responsible for preparation and follow up for collection of data related to Annual validation planner.
- Responsible for submission of qualification documents to RA as per requirement.
- Responsible for review of media fill BMR.
- Responsible for IPQA activities as per requirements.
- Responsible for review and approval of documents like Validation protocols, reports, QRM, SOPs etc..
- Responsible for the assessment & review of Change Control, Deviation, CAPA, Investigation etc..
- Responsible for approval of URS, DQ and vendor/ suppliers documents related to qualification.
Additional Responsibilities: - Ensure readiness of validation documents and responses.
- Provide training to the validation team and relevant cross-functional personnel on new validation procedures, regulatory updates, and equipment/system validations to maintain compliance and consistency.
- Participate in Vendor Qualification and Technical Evaluation.
- Monitor and manage the lifecycle of validated systems, including periodic review, change management, and revalidation, to ensure sustained compliance and performance.
- To have cost saving, quality improvement, Time saving and innovative thinking approach.
- To have good written and verbal communication skills in English language.
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.
Other facts
About Amneal India
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.
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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 Deputy General Manager, QA Validation is responsible for ensuring that validation systems are updated according to regulatory requirements and for overseeing the execution and review of qualification and validation activities. This role also involves coordinating with various departments to ensure timely completion of validation activities and preparing necessary documentation.
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