Rajan Kudale

Rajan Kudale Email and Phone Number

Mumbai, MH, IN
Rajan Kudale's Location
Mumbai, Maharashtra, India, India
About Rajan Kudale

I have done my M.Sc. in Organic Chemistry from Shivaji University. I have been in the field of Pharmaceutical over 30+ years.Having exposure & knowledge of Good Laboratory Practices (GLP), Quality Management System (QMS), Current Good Manufacturing Practice (cGMP), Change Control System, Deviations, Incidence, Out Of Specifications (OOS), Out Of Trend (OOT), Corrective and Preventive Actions (CAPA), Risk management, Stability studies of various dosage forms, Laboratory incident, Equipment's/Instrument's Qualification & Validation, Instruments calibration, Analytical methods validation, Working & Reference Standards Management, Analyst qualifications, Cleaning validation, SOP's, STP's, Internal Audits, Vendor Audits, Training to the personnel, Document reviews of QC/QA, Document preparation of Level-1, Level-2 & Level-3. Specialties: Injectable sterile pharmaceuticals, aseptic processing and terminal sterilization (Small Volume Parenterals).

Rajan Kudale's Current Company Details
MICROPURE PARENTERALS PRIVATE LIMITED

Micropure Parenterals Private Limited

View
Manager-QA and QC
Mumbai, MH, IN
Website:
micropure.in
Employees:
31
Rajan Kudale Work Experience Details
  • Micropure Parenterals Private Limited
    Manager-Qa And Qc
    Micropure Parenterals Private Limited
    Mumbai, Mh, In
  • Micropure Parenterals Private Limited
    Manager-Qa/Qc
    Micropure Parenterals Private Limited Dec 2016 - Present
    Wada,Palghar,Maharashtra
    (1) Handling complaints, CAPA, Change control, OOS/OOT event, Deviation (investigation & timely closing of complaints).(2) Imparting GMP training to staff as well as shop floor people.(3) Conducting internal audits, vendor audits. (4) Leading the team to face regulatory audits, third-party audits.(5) Leading a team of Executives and Officers and responsible for Quality Management system in the plant.(6) Maintenance of quality systems, and procedures that ensure compliance with Good Laboratory Practice.
  • Septodont
    Manager-Qa/Qc
    Septodont Jun 2014 - Dec 2016
    Taloja, Navi Mumbai
    (1) Responsible for the implementation of cGMP, GLP and QMS.(2) Responsible for scheduling and imparting the training to the people as per the training need identification with the help of HR and Plant Head, to create the awareness among the people.(3) Making sure that critical deviation, customer complaints are investigated and resolved and implementation of the corrective and preventive action. (4) Release or rejection of raw materials, packaging materials, intermediates and finished products based on the assessment of results against specifications. (5) Participate in investigation and approval of events (deviations), temporary changes, non- conformance, out of specifications results and failures. (6) Co-ordination with various Dept. (Stores, Purchase, HRD, Accounts, Production, Maintenance etc.) for smooth - functioning of department activity. (7) Leading a team of Assistant Managers, Executives and Officers and responsible for Quality Management System in the plant. (8) Responsible for review and approval of Master documents BMR/BPR/ RM/PM/intermediate/FP Specifications, protocol and all department SOPs. (9) Responsible for development of Artwork for local product. (10) Communication with abroad people through mail and Telephone/Video conferencing for smooth functioning/reporting of work. (11) Planning and monitoring for timely sampling and analysis of incoming Raw and Packing materials.(12) Part of recruitment process for the selection, interviewing and final selection of appropriate and the competent staff of Store, Production, QA/QC in coordination with HR, Plant Head and General Manager. (13) Ensure that safety policy is strictly followed in the laboratory.
  • Elder Pharmaceuticals
    Dy.Manager-Qa/Qc
    Elder Pharmaceuticals Jun 1992 - May 2014
    Patalganga,Raigad
    (1) Leading a team of Assistant Managers, Executives and Officers and responsible for Quality Management system in the plant.(2) Preparation, Review & implementation of Validation Documents for New Equipment's and Instruments: URS, DQ, SAT, FAT, IQ, OQ & PQ.(3) Handling complaints (investigation & timely closing of complaints).(4) Routine monthly and annually managerial reporting system.(5) Co‐ordination with various Dept. (Stores, Purchase, HRD, Accounts, Production, Maintenance etc.) for smooth ‐ functioning of dept. activity.(6)Review of Change control, Deviation, Non‐conformance and CAPA.(7) To investigate and resolve quality related customer complaints.(8) Ensure that approved quality systems are followed.(9) All activities of QC laboratory of both chemical instrumental & microbiological.(10) Update latest Pharmacopeia and regulatory requirement in routine work.(11) Conducting internal audit (Self‐Inspection) and Vendor audit.(12) Release the Raw / Packing material for production and finished product for sale.(13) To established the protocol for process validation, method validation, DHS, Autoclave, HVAC, Water system and process simulation (Media fill).(14) Maintenance of departmental quality systems like calibration & maintenance of instruments and equipment's.
  • J. Parikh & Co.
    Chemist
    J. Parikh & Co. Aug 1990 - Apr 1992
    Mumbai Area, India
    (1) Day to day routine chemical and instrumental analysis of raw material and pharmaceutical product, edible oils.(2) Handling of sophisticated instruments like UV spectrophotometer, Karl fisher, IR etc.

Rajan Kudale Education Details

Frequently Asked Questions about Rajan Kudale

What company does Rajan Kudale work for?

Rajan Kudale works for Micropure Parenterals Private Limited

What is Rajan Kudale's role at the current company?

Rajan Kudale's current role is Manager-QA and QC.

What schools did Rajan Kudale attend?

Rajan Kudale attended Shivaji University, Kolhapur, Shivaji University, Kolhapur.

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