We are seeking a dynamic and experienced Process Engineer who will be responsible for managing batch material requisition, documentation and operational efficiency in the manufacturing environment. This role ensures that all production activities are carried out in compliance with regulatory standards and company protocols, aiming to enhance product quality and process efficiency.
Job Role :
- Raise material requisition and receive the materials from stores.
- Preparation of Daily report, formats and BMRs as and when required.
- Online BMR entries to be updated and all formats of relevant SOPs to be completed.
- Preparation of SOPs for the vials and cartridge processing area and ensure training of it for the line operators.
- To improve the yield of the lines and to reduce the rejections.
- To prepare the samples as per the customer requirements and complete the entries in BMR and logbooks.
- To complete the SAP entries for the line activities online.
- To ensure that the completed batch pallets are transferred to ready to ETO area / nonsterile FG area and line is ready for next batch processing.
- Responsible for daily machine output as per machine speeds.
- Manpower and shift handling
- Knowledge of Raw material and Packing materials for Sterile packing.
- Knowledge of Product Sterilisation or ETO sterilisation.
- Knowledge of Clean room practice and gowning procedure.
- To check and attach the NVPC records along with BMR for the processed batch and submit the BMR to QA next day.
- Ensure establishing & implementing IMSU / EHS system, etc.
Educational Qualification and Experience :
BTech / B. Pharm / BSc / MSc2-8 years of experience in pharmaceutical industry onlyFamiliarity with clean room facility, documentation, pharma processingCompetencies and Skills :
Strong interpersonal and communication skills.Strong proficiency in data handling, ensuring accurate interpretation.Proficiency in local languages and English, both written and spoken, to facilitate effective communication with employees and stakeholders.Thorough knowledge of MS Excel, Word. PowerPoint, SAP etc.Manpower handlingTeam player with the ability to collaborate across functions