Officer/Sr. Officer API Onco Manufacturing
2 - 9 Years of Experience
Not disclosed 
Full TimeApothecon Pharmaceuticals Pvt. Ltd.
Vadodara, Gujarat, India
Posted on 18-09-2024
130 Views
1 Vacancy
Description
- Manage and monitor day-to-day manufacturing activities for oncology-related APIs (Active Pharmaceutical Ingredients).
- Ensure adherence to Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMP), and safety protocols in the production environment.
- Assist in the execution of production batches as per the predefined production schedules.
- Prepare and maintain batch manufacturing records (BMR), ensuring completeness, accuracy, and adherence to regulatory requirements.
- Ensure proper documentation for all steps of the production process, including any deviations or issues faced during production.
- Collaborate with Quality Assurance (QA) and Quality Control (QC) teams to ensure that product quality meets defined standards.
- Perform in-process quality checks to ensure that all parameters are within defined specifications during production.
- Participate in internal and external audits, ensuring readiness and compliance with regulatory standards (e.g., USFDA, EMA, CDSCO).
Category
Pharmaceuticals
Functional Area
Production / Manufacturing
Preferred Education
MSc (Master of Science)BSc (Bachelor of Science)
Key Skills
Attention to DetailProblem solvingManufacturingTeam WorkCommunicatiom
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