Associate -Technical Services (Inj)

Job Description Summary

This role is the deft in technology transfer of Injectable products to manufacturing plant, scale up and demonstrate the technical capability and accessibility to current portfolio and pipeline products. The incumbent will also be jointly responsible for achieving targeted product execution goals of department / organization. He would be responsible for Documentation, Evaluation and Monitoring of batches at Manufacturing site.

Job Description

• To perform product transfer activities of sterile products assigned by Manager/Sr. Manager /Designee.
• Execution /Supervision of Trial, Engineering/Scale-up & Submission/ Exhibit batches.
• To perform activities related to Technology transfer at site (As applicable)
• To compile Scale up trials/Scale up batches/Submission batches results, drawing conclusions.
• Prepare technology transfer documents i.e. Product risk assessment, Hold time study protocol & report, Scale-up batch protocol & report etc. (as applicable).
• Initiation of request for Creation / Extension of Material code & prepare RM & PPM.
• Day to day work on SAP, document compliance manager and track wise or other relevant software which are used for documentation work.
• Observance of the laid down standard operating procedure (SOP) as applicable at all PAR formulation sites, including workplace safety.
• To carry out the Literature search on quality management, Regulatory Guidance (as applicable).
• To Co-ordinate with cross functional teams for the timely completion of assigned activities.
• To work out a project plan specifying timelines and target completion dates.
• To support in documentation for Investigations, Deviations, Incidents, Out Of Specifications, Out Of Trends and Non-conformances as applicable to R&D.
• To perform work allotted by Manager/ Sr. Manger/ designee
• Bachelor of Pharmacy / Master of Pharmacy (Full Time)
• Required Experience: 4 – 8 yrs.
• Good exposure / Experience of technology transfer / MSAT / Technical services / Production for regulated market in injectable / sterile products.
• Hands on Experience with GMP Documentation activities.
• FDA regulations and guidance’s
• GMP/GDP
• Good communication skills and smart thinker.
• Work in a transparent environment, Proactive and Innovative.