Officer - QC Analytical RMPM

Job Description

• Preparation of SOPs/ STPs for Raw Material/ Packaging Material/Consumable material and preparation of Raw Material/ Packaging Material/Consumable material specifications as per QC format after receipt from R&D.
• To update Specifications/ STPs in line with the Pharmacopoeial changes.
• Timely sampling/ testing with online documentation of Raw Material/ Packaging Material/Consumable material as per approved specifications/ test procedures.
• Timely shipment and tracking of RM/ PM samples to commercial laboratories for the outsourced test parameters.
• Management of RM/ PM retention/ reserve samples and their related documents.
• Routine sampling of water as per the approved sampling schedule following the approved sampling procedures and perform timely testing with online documentation. And preparation of trends of water samples as per the approved frequency.
• Preparation of equipment URS/ Qualification protocols/ reports pertaining to Raw Material/ Packaging Material.
• Preparation and execution of study protocols and reports pertaining to Raw Material/ Packaging Material.
• Perform In-house calibration/ verification of Raw Material/ Packaging Material/Consumable material equipment’s as per the approved procedures and calibration/ verification frequency.Routine monitoring and updation of Temperature/ Humidity records of equipment’s including but not limited to stability chambers/ Incubators/ deep freezers/ Refrigerators/ Walk-in chambers/ Cold rooms etc.
• To report any Deviations/ OOS and Safety risks to the supervisor as and when observed.
• To attend all GMP/ On-job/ additional trainings as per the approved training matrix and update the training records.
• To ensure cGMP compliance in laboratory.
• To ensure safety compliance at work place.
• To comply with the current & subsequent EHS management system, procedures, guidelines, policy, practices, requirements, and applicable legal compliances on site.
• Additional Job Responsibilities:
• To initiate and track timely procurement of chemicals/ Reagents/ consumables and maintain their inventory records.
• To perform sample management activity through SAP/ manual procedures and perform timely handover of test data sheets and sample to respective laboratory/ section.
• Any responsibility assigned by the superior from time to time.

Work Experience

2 to 3 years 

Education

Competencies