API Production Specialist

2 days ago

Mysore, Karnataka, India beBeePharmaceutical Full time ₹ 5,00,000 - ₹ 10,00,000

This production role involves working with a leading manufacturer of Active Pharmaceutical Ingredients (APIs). The ideal candidate will have hands-on experience in API production and be responsible for executing batches while adhering to strict standards of quality, safety, and compliance.

Key Responsibilities
  • Production Planning & Execution: Execute production batches according to plans and targeted commitments, ensuring compliance with cGMP and safety requirements.
  • Quality & Compliance: Ensure adherence to all process instructions as per the Batch Manufacturing Record, maintain good housekeeping, and adhere to cGMP, Safety, Health & Environment (SHE) standards.
  • Documentation: Perform online document entries with legibility, review batch records for accuracy before handing over to QA, and ensure proper labeling and storage of raw materials and APIs.
  • Reporting & Investigation: Immediately report deviations/incidents and support QA in investigations related to OOS, Deviations, CAPA, Incidents, and validations.
  • Maintenance & Monitoring: Monitor and control the manufacturing environment, perform scheduled preventive maintenance and calibrations, and conduct sanitization activities in the department.
  • Inventory Management: Reconcile stock records at regular intervals to maintain accurate inventory.
Required Skills & Qualifications
  • Experience in API production.
  • Strong knowledge of cGMP, safety, and environmental regulations.
  • Proficiency in handling Batch Manufacturing Records.
  • The ability to work in a production environment and perform thorough documentation.
  • B.Tech in Chemical Engineering, M.Sc in Chemistry, Diploma in Chemical, or B.Sc in Chemistry.
Why Choose This Role?

This position offers an opportunity to work with a reputable company that values quality, safety, and compliance. As a Production Associate, you will contribute to the development of high-quality APIs that meet international standards.

You will have the chance to develop your skills and expertise in API production, quality assurance, and compliance. Our team is dedicated to providing ongoing training and support to ensure your success in this role.

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