Quality Assurance Control

Shivanand T. Lokhande

E-Mail: acd5sx@r.postjobfree.com, Mobile: +91-981*******

Seeking senior level positions in Quality Assurance, Contract manufacturing Quality Assurance, Operations and

Compliance functions with a high growth-driven organisation in the Pharmaceutical industry.

Professional Digest

Seasoned professional with about 22 years of experience, 10 years in Quality control and 12 Years in

Quality Assurance, Managing CMO QA activities, Quality system Inspections, Audits & Compliance Reviews,

Quality Control, in the Pharmaceutical industry.

Presently associated with Sandoz Private Limited, Mumbai as Manager-Quality Assurance Commercial

operations.

Certified GMP Auditor by Novartis, Basel

Credited with significant contributions towards:

Quality Management at Third Party manufacturers for Sandoz Com. Ops. Division.

GMP audits of around 5 API; 20 non sterile formulations; 2 sterile formulations manufacturing facilities, as

Lead / supportive Auditor.

Preparations for and participation in more than 10 Authority inspections

Possesses strong skills in Third Party Quality management and GMP Auditing

Effective communicator with strong analytical, coordination and leadership skills

Core Strengths

- Strategy Planning - Quality Assurance - Quality Control

- Quality Systems Set Up - Process Validation - Quality Systems Enhancement

- Audits, Inspections - Documentation - Lab Operations

- Compliance Reviews - Training & Development - Cost Optimisation

Employment History

Sandoz Private Limited, Mumbai (Generic division of Novartis), since February 2001.

Responsibilities

Monitoring Quality compliance at 17 Contract Manufacturing Organisation (CMO) locations.

Responsible for Quality Assurance activities for more than 250 SKUs in various therapeutic segments.

Setting up and Implementation of Novartis Quality Modules & Third Party Assessment Standards at CMOs.

Evaluation of potential business partners as contract manufacturing organisations (CMO). Assessment

based on the GMP compliance status, manufacturing capabilities, complaints etc.(CQRA)

Guiding and monitoring CMO and the C&FA network for Quality Systems implementation & Compliance.

Product Dossier evaluation of new FDFs.

Evaluation of Stability data, Product Quality Reviews.

Handling customer complaints, investigations.

Responsible for Change controls, Deviations management, monitoring & implementation of CAPA, related

to contract manufacturing sites.

Member of technology transfer team.

Responsible for Quality Risk assessment of Analytical & manufacturing process and Validation activities.

Responsible for product release to market (Finished products)

Responsible for providing support to Regulatory affairs for registrations of FDF, renewal, site variations for

various countries.

Monitoring the GMP compliance at the CMO and product supply chain.

Planning, scheduling and conducting GMP Audits of FDF manufacturers (CMO), API Vendors, Central

warehouses & Distributors of Sandoz. This includes organising the audit, audit logistics, preparing audit

agenda, conducting audits, compiling audit reports and maintaining regular follow-up for compliance reports.

Distinctive Highlights

Successfully handled the following GMP Audits as Lead Auditor/ Support Auditor:

API Manufacturers: 5

FDF Manufacturers–Oral: 20

Injectables: 2

Implementation & monitoring of the following quality systems across all 17 contract manufacturing sites of

Sandoz.

Change Control

Deviations and Failure Investigations

OOS/ OOE

CAPA

Customer Complaints & Product Recall

Facility & Equipment Qualification

Computer System Validation

GMP Documentation & control

GMP Training

Vendor Approval

Support during the project activities

Implementation of Third party Assessment Standards at CMO locations

Significant contribution for establishing the Quality process flows for release and distribution during SAP

harmonization project (SHAPE)

Setting up new central warehouse at Ambala.

Initiated various GMP upgradation project encompassing the implementation of QA and Quality Systems for

various formulations contract manufacturing sites of Sandoz.

Conducting GMP Training Sessions and Workshops on

Quality Systems.

Management & Preparation for Inspections

Overview of Quality systems to Sandoz Field force.

Cipla Limited, Mumbai during January 1997 to June 2001

Joined as Management Staff in QC and rose to the position of QC Section Head QC of LL

Manufacturing.

Deliverables

Planning, scheduling and conducting QC Audits of Loan Licensing FDF manufacturers. This includes

organising the audit, audit logistics, preparing audit agenda, conducting audits, compiling audit reports and

maintaining regular follow-up for compliance reports. Implementation of Good laboratory at all ( 50 CMOs)

Management of analysis & timely reporting of various formulations like Oral solid dosage, Liquid & Dry

Syrups, Ointments (Sterile & Non Sterile), Sterile Injectables (Cephalosporin) etc.

Routine analysis and release of finished products.

Hands on experience of handling laboratory instrument, HPLC, GC, IR, UV spectrophotometer,

Potentiometer etc.

Warren pharmaceuticals Pvt. Ltd, kandivali ( During March 1993 to December 1996)

Executive – QA/QC

Analysis & release of RM, PM & Finished products of Sterile formulations & medicated tooth pastes

(Strontium chloride & Formaldehyde tooth pastes)

Microbiological Assays of antibiotic formulations

Sterility testing of eye drops & injectables

Participated in Media fill activities

Pharma Medico (India) Pvt. Ltd. Jogeshwari (W) during January 1989 to March 1993.

QA/QC Chemist

Setting the Chemical laboratory systems and operations.

Supported set up of Quality Control laboratory systems and operations

Distinctive Highlights

Participated in several Quality control functions: Performed microbiological & chemical analysis of raw

material, packaging material & finished products supporting non sterile & sterile formulations manufacturing

activities (Sterile & non sterile ointments).

Executed ‘in process monitoring’, environmental monitoring during aseptic filling process, sterility testing of

sterile ointments)

Participated in validation & qualification activities of

Media Fill

Qualification of steam sterilisers, dry heat sterilisers and vial washing machines

Academia

M.Sc. (Chemistry) from Salem University,

B. Sc (Chemistry) From Mumbai University.

PGDBA (Operations) Post Graduate diploma in Business Administrations from Welingkar Institute of

Management and research, Mumbai.

Professional Development

Received Global Pearl Award from Sandoz for superior performance in H1 2013.

Certified Auditor by Novartis, Basel in April 2012.

Certified GMP Auditor by Sandoz Corporate QA, in September 2006.

Approved by the Maharashtra FDA in the areas of ‘Microbiological analysis & Sterility testing’ and ‘chemical &

Instrumental analysis’.

Personal Details

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Date of Birth : 9 June1969

Mailing Address : I-1, 304, Happy Home complex, Shantipark, Mira Road (East), Dist. Thane, Pin- 401107

(Maharashtra, India)

Tel. (Res.) : +91-22–28128611

Cell phone : +919*********

References : Available upon request

Contact this candidate