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Senior Production Executive

2 weeks ago

Vizag, Andhra Pradesh, India Lywo Hyderabad Full time ₹ 9,00,000 - ₹ 12,00,000 per year

We are looking for a meticulous Sr. Executive - Production to spearhead production activities and ensure adherence to stringent quality standards at Synnat Pharma Private Limited. As Sr. Executive - Production, you will play a pivotal role in managing batch manufacturing records, equipment compatibility, and various validation protocols, including process, cleaning, blending, drying, and micronization. The ideal candidate will be adept at preparing master formula records, quality equivalence reports, and standard operating procedures, while also taking the initiative for change controls and performance qualifications. This role demands a strong understanding of QMS activities, internal and external audits, and the ability to prepare comprehensive technical documentation. Coordinating with internal and external stakeholders, managing shift schedules, and ensuring regulatory compliance are also key aspects of this position. Your expertise in API manufacturing and commitment to cGMP will be essential in maintaining our high standards. You will contribute significantly to our mission of achieving global leadership in API manufacturing.

Responsibilities:

  1. Prepare, review, and maintain Batch Manufacturing Records (BMRs) and Master Formula Records (MFRs) in compliance with cGMP.

  2. Develop and update Standard Operating Procedures (SOPs) and ensure accuracy of technical documentation.

  3. Generate quality equivalence reports and other documentation required for audits and regulatory compliance.

  4. Lead validation activities, including process, cleaning, blending, drying, and micronization protocols.

  5. Conduct equipment compatibility studies and prepare performance qualification (PQ) documentation.

  6. Analyze validation data, implement corrective actions, and ensure reliability of manufacturing processes.

  7. Manage QMS activities, change controls, and impact assessments to maintain compliance.

  8. Coordinate and participate in internal and external audits, addressing findings and implementing CAPA.

  9. Collaborate with cross-functional teams including QA, Engineering, and Maintenance to ensure smooth production operations.

  10. Prepare shift schedules, ensure adequate staffing, and oversee department-specific training programs.

  11. Communicate effectively with stakeholders to resolve production issues and ensure adherence to safety and cGMP.

  12. Drive continuous improvement initiatives to enhance production efficiency, compliance, and overall quality.

General Expectations and Past Experiences:

  • Strong expertise in API manufacturing processes and cGMP regulations.
  • Experience in preparing BMRs, MFRs, SOPs, and technical documentation.
  • Proven knowledge of validation activities (process, cleaning, equipment, etc.).
  • Hands-on experience in QMS, CAPA, change control, and audit compliance.
  • Excellent communication, coordination, and training skills.
  • Ability to mentor staff and ensure adherence to safety and quality protocols.