Executive, Manufacturing Injectables at Amneal India
Ahmedabad, gujarat, India -
Full Time


Start Date

Immediate

Expiry Date

25 Jun, 26

Salary

0.0

Posted On

27 Mar, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Compounding Systems, Solution Preparation, Qualification, Validation, SIP Validation, Filtration Validation, Batch Records, Data Integrity, Troubleshooting, Sterile Injectables, Biologic Handling, Peptide Handling, Tech Transfer, Scale-Up, Leadership, Stakeholder Management

Industry

Pharmaceutical Manufacturing

Description
Key Responsibilities:-  Lead batch preparation, compounding, solution preparation activities- Manage qualification & validation: mixing vessel qualification, SIP validation, filtration validation- Ensure correctness of batch records, logbooks, and data integrity compliance- Lead troubleshooting for compounding deviations and filtration failures- Coordinate with QA/Engineering/Warehouse for seamless production  Technical / Functional Skills:- Expertise in compounding systems and solution preparation- Strong qualification & validation experience (IQ/OQ/PQ, CIP/SIP validation)- Knowledge of filter validation, hold time validation, and mixing studies- Strong understanding of formulation, stability, and compounding dynamics  Behavioral Competencies:- Strong leadership and decision-making abilities- Excellent communication and stakeholder management- High compliance and documentation discipline  Injectables–Specific Expectations:- Experience leading compounding operations for sterile injectables- Understanding of biologic/peptide solution handling- Ability to manage tech transfer & scale-up activities
Responsibilities
The Executive will lead batch preparation, compounding, and solution preparation activities, while also managing qualification and validation processes for equipment like mixing vessels and filtration systems. Key duties include ensuring correctness of batch records, logbooks, and data integrity compliance, alongside leading troubleshooting for deviations.
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