AGM |DGM | GM - QC, Bio-mfg. Biosmilars

Job Title:

AGM/DGM/GM

Department:

QC , Bio-mfg.

Plant / Division /               Sub-Dept.:

Bio-manufacturing facility, Pithampur

Location:

  Pithampur, Indore

Role:

·     Responsible and accountable for leading Quality Control team and overall supervision of Quality Control function to achieve targets by delivering and improving process consistency, product quality and compliances.

·     Also responsible for Method transfer from R&D to Manufacturing

Key Responsibilities:

·     M anaging the team and overseeing day-to-day operations, to ensure the execution of all the process activities is carried out as per the quality systems and GMP guidelines .

·     Mon itoring ongoing CMO activities (As applicable) and Tech transfer for new processes and scale-up.

·     Handling deviations, change controls, risk assessment documents, etc. Lead the investigations and coordinate with cross function al teams to facilitate the investigation process. Ensure effective corrective and preventive measures are implemented in a timely manner.

·     Prepare and review of equipment qualification documents, analytical method transfer protocols, technology transfer protocol/ report, validation protocol and its respective reports. Also document review for cross functional departments. E.g. SOPs, BMRs, SPRs and other GMP documents etc..

·     Managing the work force and team building: Interviewing, training, motivating, developing, recognizing, and managing the performance of subordinates .

·     Active participation in internal audit, vendor / service provider audit and CMO audit.

Functional Knowledge / Skills:

·        General

·        Specialized

·     Problem solving, Leadership and Team management.

·     Good Communication skills.

·     Good documents drafting and reviewing skill.

·     Good MS office Knowledge.

·     Analytical method validation and transfer, Bioassay method development and validation for Quality Control as regulatory guidelines.

·     Good knowledge of Quality sciences.

·     CMO operations.

Key Competencies:

·        Qualification

-    Essential

-    Desirable

·        Experience

-    Essential

-    Desirable

M.Sc. /M.Tech

Over 15 years of exp