Deputy Manager / Manager - Technical Services (topical)

  • Visakhapatnam
  • 10-15 lakh
  • 5-10 years
  • 19 May 2015

  • Quality Control - Product/ Process

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Quality Excellence- Trouble shooting & Root Cause Analysis-
Interact with CFTs (Production, QC, QA,RA ) post the briefing of failures/deviations in process/product to further understand critical process, analytical and quality attributes; apply latest quality and statistical tools; perform systematic and scientific principles based investigation; perform experimentation and trials; collate and investigate experimental data; seek R&D and expert advice support as needed TO IDENTIFY THE ROOT CAUSE; check the reliability of proposed corrective actions either through experimentation or actual batch
Gather all the pertinint learning during root cause analysis, diagnosis , trouble shooting, implementation from quality and manufacturing excellence perspective in form of a report.
Conducting feasiblity trials on lab scale/ commercial equipment as per the requirement or plan; to study the outcome and submit reports; interact with equipment suppliersas necessaray IN ORDER TO execute the manufacturing improvement plans as per the identified issue in coordination of Production Team .
Execute the Exhibit batch , Pilot batch as per the scheduled timelines .
Execute the Site transfer batches as an when required as per the scheduled timelines .
Ensure the batch execution documents like BMR,BPR , Hold TIme Protocol ,Stability Protocol ,PVP ,sampling protocol are in place before the batch manufacturing .
Preapare the relevant manufacturing check lists and guidelines by refering to standarad unit opreration documentation and intetracting with operating personnel IN ORDER TO support manufacturablity evaluations of new products .
Ensure the relavent equipment , Accessories and tools are available before execution of batch .

M. Pharma with year 7-8 years of experience in Topical product like Cream ,Ointment ,Solution ,Lotion Gel.
Good understanding of investigational tools and root cause analysis; exposure to application of QbD, PAT and DoE; sound basics of formulation science, unit operations, scale up technologies, analytical methods and trouble shooting processes, working knowledge of Topical Drug Product formulation manufacturing .

Competencies/Skill sets for this job

Manufacturing Quality Evaluation Equipment Timelines Protocol

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