
Dinesh Thaker
Manufacturing / Mechanical
About Dinesh Thaker:
Respected Sir / Madam,
I have understood from the job portal (Google) that the Jpb Title : Process Engineering is vacated in your esteemed organization. please find enclosed herewith my application & CV for your kind consideration.
Having worked within the Specialty Chemicals, API & Intermediates industry for over 28 years, I have developed a wide range of skills that would meet, and exceed the expectations for the role.
During my career I have had many achievements, including the following areas:
1) Entire Operations activity with Budgeting, production planning, capacity planning, capacity Utilization, desired Yields, Quality, Process and Cleaning Validation.
2) Cost reduction through yield improvement, process time cycle reduction, solvent recovery improvement, Increase of Production without / with investment.
3) Good Manufacturing Practices Implementation as per USFDA / ICH Q7 / WHO guideline.
4) Corrective Action / Preventive Action (CAPA), Quality Risk Management, HSE, Change controls Procedure, training & its implementation.
5) Managing Regulatory / Customer Audit & compliance.
6) Product Quality / Particle Size improvement as per the customer requirement.
7) TQM tools Implementation.
8) Effective MIS Implementation.
9) AT Udaipur (Mavli) we have created three green field projects (API & Intermediates) from the basic stage like conversion of land for industrial use.
10) Selected different products (API & Intermediates) for all three sites.
11) Initiated Environment Clearance (EC) with all required documents and after getting EC construction of entire facility like Raw Material keeping area, production area, QC, QA, IPQC, Powder processing area (Clean area), ETP, MEE, OHC & installed reactors, filters, CF, Dryers, Clean area equipment, QC equipment & instruments etc. all activity done as per cGMP norms & ICH Q7 requirements.
12) Initiated Consent to establish Then Consent to Operate, FDA Approval & after getting approvals we have started production activity.
I look forward to hearing from you soon.
Thanks & Regards,
Dinesh Thaker
Experience
Production, Process Engineering, EHS, Administration, cGMP. TQM, Training, Customer & Regulatory Audit compliance.
Education
B. Sc. MBA (Operatins)
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