- Production Planning as per demand from the sales team, reschedule to meet sales exigencies.
- Keep track of RM/PM etc to meet monthly requirements, Coordination with SCM
- Production activities in compliance with cGMP, EHS and other Safety Guidelines/Requirements
- Ensuring that all Production is kept in a ready state to avoid any production loss
- Physically validate and Evaluate plant and Surroundings to ensure compliance with High Standards and cGMP.
- Ensure that work is allocated properly to officer/ Executive based on their competency to meet the Daily Production Plan. Check that they are properly trained, gowned and well protected for the assigned work.
- Check that all the equipment (including balances) used in the dept. are calibrated, qualified, validated, clean, and in good condition for use.
- Ensure to check the Area, Equipment Cleanliness & Environmental Condition before the commencement of Manufacturing & Packaging of products.
- Check that Manufacturing and Packing of batches is carried out strictly as per the procedure laid down in relevant SOP’s & BPR only.
- To prepare revenue & Capex budget for the respective area on a yearly basis.
- To minimize quality failures & reduce NPA in coordination with SCM
- To maintain stock records of Intermediates & APIs and Ensure consistent availability besides ensuring the availability of other consumables parts, spare stationaries, etc..
- Debottlenecking & capacity enhancement.
- Minimizing wastage by optimizing resource utilization
- Maintaining Plant disciplined and Establishing performance culture with timely completion of KRA, PMS
- Proper Maintenance of All docs and available readily as and when required.
- To check the online filling of records & online submission to the QA department.
- Review SOP’s/ URS/ BPR/ Protocol/ Investigation report for regulatory compliance and actual practice.
- Departmental approval for change control/ Deviation/ CAPA in OASIS LIMS.
- To evaluate proposed changes in the production process or equipment and approving any documents as per SOPs.
- Prepare and submit reports as & when required
- To ensure the preparedness of regulatory, customer & safety audits of the plant.
- To ensure audit compliance and respond to QA for Non-Compliance Reports of internal, customer & regulatory audits.
- To maintain departmental OJT training records & coordinate with QA for internal audits.
- Create a high standard of safety culture in the plant/manufacturing area
- Coordinate with the EHS department for the HAZOP study of process/product / PMAs.
- Ensure to use PPEs at Shop Floor.
- Interact and coordinate with respective functional heads to resolve issues related to RM-PM, transferring & receiving materials/ solvents, dispatch of FG, Purchasing of consumable goods, financial issues, QC related issues, HR-related issues, modification/preventive maintenance of equipment or facility.
- Co-ordinate with Process Excellence Lab/ R&D for resolution of issues related to development Batches of new products/yield/quality improvement.
- Attend a meeting, a seminar as & when required on a daily, weekly & Monthly Basis.
- Ensure to conduct CFT meetings in plant and present factory performance on a monthly basis.
- Interested Candidate can apply cv email@example.com
Required Candidate profile
- Good experience in Production at Pharma(API) Organisation
- Strong in Chemical Engineering
- Good Leadership
- Team Building
- Good Analytical Skill
- Good In Communication & Co-ordination
- Presentation skill
Qualification: B.Tech/B.E Chemical, M.Tech – Chemicals
Experience: 13-17 Years
Mr. Mayur Dalal