MANSING KORDE

**** ******* ***, ********* ** ****1

acs1di@r.postjobfree.com 410-***-**** (h) 443-***-**** (c)

SUMMARY

Quality, scientific and compliance minded Analytical & Quality Control Laboratory Management

Professional with proven FDA track record. Extensive experience in Quality Control, Analytical Research and Development, Quality Assurance & Quality Operations. Work history includes Pharmaceutical (API, Solid dosage, Injectables).

Highly effective in providing overall leadership, technical direction and administration to the laboratory staff.

Key strengths in management, mentoring and root cause analysis and resolution of problems impacting product quality.

Solid background in current FDA analytical regulatory requirements for ANDA submissions.

MAJOR ACCOMPLISHMENTS

Set up & maintain state-of-art cGMP compliant analytical laboratories, managed activities of Quality Control and analytical development groups, and promoted unified goals for effective collaboration, teamwork and mutual respect.

Established and met group goals and objectives in line with Company priorities. Built self-directed work teams, provided timely response to customers needs.

Identified key chemists and provided coaching and direction effectively building centers of technical excellence within the groups.

Successful interaction across multi-department and multi-discipline divisions.

Handling of FDA inspections & prepared response to FDA observations.

Prepared response to FDA in case of ANDA deficiencies.

Trained in six sigma, which helps in handling problems cost effectively and timely manner.

Lead Analytical method development/validation/transfer activity.

Prepared cost effective budget for laboratory operations.

PROFESSIONAL EXPERIENCE

JUBILANT CADISTA PHARMACEUTICAL INC, Salisbury, MD, From 02/2004 to 12/2015

Associate Director, Quality Control

Oversee Quality Control & Analytical group by providing technical and administrative leadership.

Ensure efficient and timely testing and approval of raw material, in process, process validation, finished products, technical transfer & stability samples.

Maintain laboratory operation within cGMP, CFR, FDA, SOPs and safety guidelines.

To handle FDA and other regulatory inspections.

Review and/ or approve of all QC documentations such as SOP’s, test methods, specifications, analytical method validation protocols and reports.

Review and/ or approve of the analytical data obtained in the laboratory for accuracy and adequacy

To conduct laboratory investigations in the event of OOS and OOT results, and to support the investigations in the manufacturing facility utilizing analytical tools.

To provide training to the analysts, Supervisors and Managers employed.

Daily work distribution and follow up with Supervisors to ensure commitments being met for routine manufacturing, packaging and of stability samples.

Lead projects to successful completion of analytical method development/validation & method transfers from different sites.

To oversee instrumentation calibration, qualification and maintenance programs.

Interact with other departmental management to construct timelines for new projects.

Maintain Cross –functional liaison between Technical Services, Manufacturing, Validation, QA/Compliance and Regulatory departments.

To conduct audits of contract laboratory & vendors.

OTHER PROFESSIONAL EXPERIENCE

LUPIN LIMITED, Aurangabad, Maharashtra, India, From 09/1991 to 01/2004

Executive, Quality Control

Ensured efficient and timely testing and approval of raw material, in process, process validation, finished products, technical transfer & stability samples.

Successfully lead a team of Chemists to develop and validate analytical methods for various solid-dose drug products.

Successfully completed analytical method development for different products.

Developed and revised standard operating procedures and systems for proper functioning of the laboratory.

Performed and documented laboratory investigations.

Trained laboratory chemists.

Tested pharmaceutical raw materials, in-process and finished products for identity, strength, purity and quality utilizing sophisticated instruments like HPLC, GC following established agency guidance.

Executed the responsibility for qualification and calibration of analytical instruments.

Co-ordinated and approved preventive maintenance on analytical instruments.

Devised solutions for troubleshooting analytical methods.

Responsible for maintaining and archiving electronic data as per regulatory requirements.

US VITAMINS (I) LTD, Khed, Maharashtra, India, From 09/1990 to 08/1991

QC Chemist

Chemical & Instrumental analysis of Raw Materials, In-process samples, Stability samples & Bulk Drug products/Intermediates.

MAGNACHEM PHARMACEUTICALS PVT. LTD, Satara, Maharashtra, India,

From 03/1990 to 09/1990 as a QC Chemist

Chemical & Instrumental analysis of Raw Materials, In-process & Finished product samples.

EDUCATION

MSc, Physical Chemistry, Shivaji University, Kolhapur, Maharashtra India

BSc, Chemistry, Shivaji University, Kolhapur, Maharashtra India

OTHER KNOWLEDGE

Excellent knowledge of Microsoft Windows and Office. Working knowledge of operating BAAN & SAP system.

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