Subject: Application for the post of Validation Manager
I wish to offer my services for above-mentioned post in your kind control organization. I put before your honor my brief BIO-DATA for your kind consideration.
Personal Details :
SAVE SUNIL PRABHAKAR
At & Post – Tarapur (Holi Ali), Taluka – Palghar, Dist-palghar,
Pincode – 401502.
Date of Birth
Pass Port No:
Diploma in Mechanical Engg.
B.Tech ( Mechanical Engg.)
1.26 years of total experience in pharma plant,out of 11.6 years in M/s ‘Aarti Drugs Ltd Plot No E-22’ (USFDA, TGA, EDQM and WHO cGMP approved Plant) API plant Tarapur MIDC worked as a Asst. Manager Maintenance. (1995 to 1996—2.2 years and Apr 2002 to Aug 2012---9.4 years)
2.Worked in M/s TSSL for Sr Officer in Maintenance and project ( from 1996 to 2002)
3. Worked in the Calyx Pharmaceutical Ltd as a Head Engineering, Sr. Manager Engineering (project/maint.) from Aug 2012 to Oct 2015. (USFDA, EDQM and WHO Geneva, cGMP approved Plant)
4. Worked in the Medley Pharmaceuticals ltd. From Oct 2015 to Feb 2017 as a Head Engineering and reporting to VP operation.
5.Currently working in Lupin Ltd. FEB 2017 to till date…..
Expertise in New project /Maintenance budgeting, financial analysis, tracking & controlling costs.
Designing of the New buildings as per the cGMP.
Team Handled– 95 Nos. ( Mech./Elec./Inst/Civil etc) In-house + External Agencies.
Handling Procedures and processes for FDA approvals & Local Govt. bodies.
Day to day planning and organizing the activities for Project and maintenance.
Monitoring operation and maintenance of ETP and ZLD system maintenance consist of Primary treatment plant/Biological treatment /Clarifloculators /Aerators/ Polishing Clarifier/PTRO/SPRO. MEE Plant.
Up gradation of Production Quality and Quality by active participation in the technology transfer team for double productivity and double safety.
Experience in facing the Audits like USFDA, EDQM, TGA, WHO, Anvisa and various customers.
Overall responsible for Repair and Maintenance activities of Plant Utility, HVAC, DM and Purified water System.
Facing Statutory and Regulatory Audits, Ensure Audit Compliance for all internal and external audits. Closer of all CAPA within the timelines.
Training of Engineering Personnel internally and externally, compliance training for engineering personnel.
Project Co-ordination, implementation of approved capex.
Revenue budget review, monitoring and control.
Statistical planning and control of critical spares and inventory.
Engineering related change control and deviations review / approve through track wise, Qualification review / approval in EDMS. To review / approve all the engineering related documents or requests in EDMS.
Review and signing of engineering documents, bills, statutory documents and other relevant document.
To support and lead energy saving / conservation initiatives.
To approve purchase requisition, Service entry, GRN, RGP/NRGP requests in SAP. Printing of data of SAP for review.
Tracking of pending notifications through SAP and ensure of completion of notification / work order after completion of jobs with respective plant engineer / utility engineer.
Implementation of initiatives for quality and Safety initiated by Site leadership and Management.
To review and approve of SOPs.
Qualification reports of HVAC, Utility and Production equipment as per present standards.
Representing Engineering in investigation team at site. Closer of all investigation within the timeline.
Preparation of RCA for breakdown Maintenance.
To plan mechanical maintenance work and oversee the execution of the same.
Carry out Predictive, preventive and breakdown maintenance in co-ordination with the plant on a daily basis.
Review root cause analysis for repeated failure and effectiveness of CAPA
Allocate work plan to contractors and issue permits accordingly, on a daily basis.
Review the records of the Executives/officer’s /Technicians work on daily basis.
Ensure team to maintain the utility consumption records on daily basis.
Prepare expenditure requests for management approvals and indents through SAP environment.
Follow up with purchase department and vendors for delivery of materials.
Maintain stocks all spares and consumables required for his maintenance work.
Ensure update of all documents / status board in department.
Ensure statutory compliance of all mechanical/electrical equipments in the plant.
Worked in Companies certified USFDA, EDQM, TGA, WHO(Geneva),Anvisa,
ISRS, ISO9001, ISO14001, 5S, TPM, WCM and insures compliance and up gradation of system as per cGMP.
Execution of planned preventive maintenance, Calibrations with team of operators, supervisors working in three shifts. Qualification of machines, periodic maintenance co-ordination.
Continuous improvement in productivity and maximum asset utilization.
Ensure smooth and cGMP compliance in the utilities supply, maintenance and process machine area on 24x7 basis and Co-ordination with IPQA, QA and PPIC for smooth functioning of department.
Through continuous training developed down the line skilled workforce and improve people confidence and equipment efficiency.
Improve and implement SOPs, Protocols for validations, and other record formats relevant to repair and maintenance functions.
Use statistical tools to improve productivity and efficiency of plant. Real time monitoring of critical costs like power and fuel and arrest any wastages. Understand global regulatory expectations in engineering area to manufacture APIs, formulations, KRAMS and Intermediates and present them to various auditors, visitors.
Coordinate with the base builder to drive and ensure timely delivery of the equipments within agreed specifications and timelines.
Drive the office fit out works i.e scheduling, execution & delivery, within the budgeted cost, agreed quality and project timeline.
Designing of the New building as per the requirement.
Good knowledge in Equipment Qualification /Validation activities as per current Guidelines
Project/ maintenance of plants, equipments and Qualification/Validation of following:
New and old Equipment DQ/IQ/OQ/PQ and Periodic validation.
1.Project /Maintenance of the plant equipments as per the SOP and schedule.
2.Equipment Qualification of above list i.e. Design Qualification, Installation Qualification, Operation Qualification & Performance Qualification.
3.Doing Equipments periodic requalification’s and Validation.
4.Giving training to down line person.
5.Qualification of Buildings and Facilities
6.Material Management for the smooth operation of the plant and machinery.
7.Hands on writing of internal and vendor quality documents.
1.GMP without Worry and Hurry The ICH Q7A Requirements.
3.HVAC and Purified water
5.Clean room Standards
6.Deviation and Change control.
Ambition: To obtained a better, permanent position that allows me to utilize my skills.
Notice Period : 3 month.
CTC Present – 24.65 L
Excepted – 32.00 L
If you give me a chance, I assure you that to work sincerely to the entire satisfaction for upgration of cGMP of your organization to comply national and international standards.
(Sunil P. Save)