Eugia Pharma - Assistant General Manager - Injectables Production

Position : AGM - Production Injectables.

Experience : 14 to 18 years.

Designation : Assistant General Manager

Qualification : M. Pharmacy / Pharmacy

Experience from sterile formulation industry (Injectable)

No.of Vacancies : 1

Job Description

• Responsible to ensure all the activity in manufacturing area of lines.
• Approval of Indented Raw Materials, Primary Packaging Materials as per the production plan.
• Coordination with cross functional team in the batch planning and ensure the Process flow, Personnel flow; Material flow shall be done as per the procedures.
• To ensure compliance to the validation schedules - qualification, requalification of area, equipment, and facility.
• To Ensure Prior intimation to validation team regarding any qualification, requalification of area, equipment, and facility.
• Initiation, review, and timely closure of all QMS elements like Change control, PNC, Exceptions and CAPA as per procedure.
• Attending trainings like on job, cGMP, External and Giving training on process related SOPs.
• Updating cGMP related practices and recent regulatory up gradation to the personnel working in the shop floor to improve the systems.
• Co-ordination with training team and ensures the completion of training of all the production personnel working in respective areas.
• Following safety systems and GMP systems during the work execution.
• To ensure the compliance of all the observation of internal audits.
• Responsible for final review of in-process and Finished product batches
• To ensure air flow visualization study (smoke study) as per approved protocol / sop.
• Review and approval of CPV Monitoring Plan
• Responsible for guiding visitors and auditors for Plant visit / Audit.

(ref : iimjobs.com)

Skills Required

Training, Validation, Cgmp, Qms, Change Control, Capa