- Responsible for day to day GMR operations related activity, make the daily, weekly monthly reports.
- Ensure updated SOP in place and in use, initiate all the required documents (ie incident, Deviation, validation, SOP compliance etc).
- Verification of all process parameters, should meet the requirement .
- Ensure all equipment health checkup should be done as per plan. Coordinate with other department for any correction in case of machine failure or utility disruptions etc Follow up with maintenance team and ensure necessary action is done and maintain as per GMP.
- Ensure the daily trim & capsule grinding, sampling & labeling of bags. All the stock trim to be update in BCFT 1 system.
- Update the new color formula in BCFT1.
- Read and follow the Production Schedule and do the Planning of new colour development.
- Verify the previous day s all the melt cycle graphic information in SCADA. If found any abnormality, report and do the RCA.
- Understand and apply cGMP guidelines in Gelatin Preparation Room including labelling etc
- Ensure daily verification of equipment, weighing balance should be done.
- Ensure the RM should be stored at their location, with proper labeling and if required to send to retesting.
- Control and minimize waste of RM including trim, recyclable capsule, gel, additives and dyes to ensure cost effective production.
- Maintain record of waste gel solution, trims, capsules. Ensure disposal of the material as per SOP and guidelines.
- Maintain inventory supplies and take inventory of various items.
- Ensure changes, process improvement plans, revised procedure and other changes are being implemented in shift post training and ensure these are consistently maintained.
- Ensure area in shift, remains presentable in shift in terms of cleanliness, organized form, documentation and systems etc
- Maintain 5S in the area.
- Ensure the audit readiness in GMR area.
- Do other jobs as defined by HOD and be part of change management in general.
Environmental, Health & Safety:
- Act in compliance with all laws, regulations and policies on safety and environment, give feedback, make inspections and implement and follow up corrections.
- Ensure safe working culture in shift including safe working habits, use of PPEs etc
Quality:
- Ensure general GMP guidelines are being followed and motivate colleagues to do the same consistently.
- Responsible for in process quality control of work in progress.
- Do follow ups regularly to ensure system in place.
Key requirements:
- Degree in B.tech/Mechanical/ Diploma/B.Pharma.
- A work experience of between 4 years to 7 years in the similar role.
- Good Communication skills
