Job Description

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.

Education:

Bachelors Degree (BA/BS) B. Pharma - Required Master Degree (MS/MA) M. Sc - Preferred Master Degree (MS/MA) M. Pharma - Preferred

Experience:

12 years or more in 12 - 15 Years

Skills:

Regulatory Compliance & Validation Guidelines (FDA, EMA, ICH, WHO) - Advanced Validation Master Plan (VMP) Development & Execution - Advanced Process Validation (PV) for Oncological Injectables - Advanced Cleaning Validation (CIP/SIP) & Residue Limit Justification - Advanced Aseptic Process Validation (Media Fill Studies) - Advanced Sterilization Validation - Advanced Equipment Qualification (DQ, IQ, OQ, PQ) - Mastery Environmental Monitoring & HVAC Qualificationn - Advanced Deviation Handling, CAPA & Change Control in Validation - Mastery Analytical Quality Assurance - Advanced Equipment & Facility knowledge - Advanced Investigation - Mastery

Specialized Knowledge: Licenses:

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.