Plant Director
Laboratories Genpharma
Keywords
Auditing
Application Programming Interfaces (APIs)
Quality Management
Biopharmaceuticals
Pharmaceuticals
Product Engineering
Packaging and Processing Duties
Medical Material
Api Design
Plant Operations
Skills
A Quality Professional with over 22 years of experience and 15 years as Lead Quality Auditor, Quality Assurance and Plant Operation of Formulation and API (Solid & Liquid Oral and Sterile Products) and API Facilities, Validation, GMP, GDP and GLP Auditing.
More than 1000 site audits are performed for the API manufacturing site, Biologics, Finished product formulation site, CRO for Formulation ( Sterile, Oral and Semisolid) and API development, Pharma packaging and accessories materials site, Radioisotopes materials, Medical devices and Computer system audits.
More than 1000 site audits are performed for the API manufacturing site, Biologics, Finished product formulation site, CRO for Formulation ( Sterile, Oral and Semisolid) and API development, Pharma packaging and accessories materials site, Radioisotopes materials, Medical devices and Computer system audits.
Project history
09/2009
-
05/2011
Responsible for overall Plant operation of Solid oral dosage facility. Responsible for the overall
Operation of the Formulation development centre. Working in the capacity of the Plant's head and
handling of all the activity of Quality Assurance, Quality Control, Production, Maintenance, and
Warehouse. Administration and expansion of the Plant, upcoming formulation projects. Preparation
and execution of production planning. Organise and control overall production, Formulation
Development activities. Make daily production schedule, organise and control activities of Tablet,
Capsule and Parenteral. Procurement of Raw materials and Packaging materials as per production
plan. Purchase of materials and machines for expansion as per plan. Provide training for newly
appointed skilled and semiskilled staff. Enforce the latest developments in cGMP. Wastage
minimisation and apply methods to its control.
Operation of the Formulation development centre. Working in the capacity of the Plant's head and
handling of all the activity of Quality Assurance, Quality Control, Production, Maintenance, and
Warehouse. Administration and expansion of the Plant, upcoming formulation projects. Preparation
and execution of production planning. Organise and control overall production, Formulation
Development activities. Make daily production schedule, organise and control activities of Tablet,
Capsule and Parenteral. Procurement of Raw materials and Packaging materials as per production
plan. Purchase of materials and machines for expansion as per plan. Provide training for newly
appointed skilled and semiskilled staff. Enforce the latest developments in cGMP. Wastage
minimisation and apply methods to its control.
01/2008
-
09/2009
Manager Quality Assurance
ORION Corporation
Global CGMP/GLP Auditor for Orion Corporation for Formulation and API facilities. Screening,
Auditing of companies for In Licensing and finalisation of Agreements for commercial and Quality
aspects for generic and speciality products. Selection and Auditing of CRO and CMO. Regular
monitoring of CRO for the activities like Pharmaceutical services, Clinical research, Bio service and
Drug Development for the corporation's various organisation. Negotiate and place the
Quality/Technical Agreements with the manufacturing sites and Distributors. Vendor Qualification
and Audits as per ICHQ7/ EUGMP and IPEC, Auditing and Licensing Activities for a company in the
area of speciality products, Animal Health, and Diagnostic Division at Orion Corporation.
Auditing of companies for In Licensing and finalisation of Agreements for commercial and Quality
aspects for generic and speciality products. Selection and Auditing of CRO and CMO. Regular
monitoring of CRO for the activities like Pharmaceutical services, Clinical research, Bio service and
Drug Development for the corporation's various organisation. Negotiate and place the
Quality/Technical Agreements with the manufacturing sites and Distributors. Vendor Qualification
and Audits as per ICHQ7/ EUGMP and IPEC, Auditing and Licensing Activities for a company in the
area of speciality products, Animal Health, and Diagnostic Division at Orion Corporation.
03/2005
-
12/2007
Quality Assurance Assistant Manager
Glenmark Pharmaceuticals Ltd.
To ensure effective implementation of the Quality Management System as per cGMP and
International requirements at all Manufacturing, Testing and Distribution levels. To interact with
external auditors and to ensure compliance with any Inspectional Observations. To co-ordinate for
Preparation, Review, Revision and Approval of SOPs of all functions, viz. QA, QC, Production,
Warehouse, Engineering and P&A. Planning Organizing, Leading and performing self-inspection.
Follow-up for the Preventive and Corrective actions for observed Non-conformances. Coordinate for
Qualification (DQ/IQ/OQ/PQ) of Equipment, Instruments and Utilities for all Oral and Ointment
formulation including API. Commissioning and qualification of Utilities (HVAC, Water systems,
Compress Air, Nitrogen,), Computer systems, Plant equipment like Oral and ointment facilities.
Processes. Preparation of Apex documents like Site Master File, QA Manual, Training Manual and
VMP. Overall performance of cleaning validation program via CVMP to reports and Process
Validation. Responsible for Third-Party Audits, Vendor Audits and Vendor Certification. Perform
training of the Technicians, Executives / Officers and Managers of all functions at Glenmark Pharma's
location. Responsible for hosting and handling international regulatory auditors.
International requirements at all Manufacturing, Testing and Distribution levels. To interact with
external auditors and to ensure compliance with any Inspectional Observations. To co-ordinate for
Preparation, Review, Revision and Approval of SOPs of all functions, viz. QA, QC, Production,
Warehouse, Engineering and P&A. Planning Organizing, Leading and performing self-inspection.
Follow-up for the Preventive and Corrective actions for observed Non-conformances. Coordinate for
Qualification (DQ/IQ/OQ/PQ) of Equipment, Instruments and Utilities for all Oral and Ointment
formulation including API. Commissioning and qualification of Utilities (HVAC, Water systems,
Compress Air, Nitrogen,), Computer systems, Plant equipment like Oral and ointment facilities.
Processes. Preparation of Apex documents like Site Master File, QA Manual, Training Manual and
VMP. Overall performance of cleaning validation program via CVMP to reports and Process
Validation. Responsible for Third-Party Audits, Vendor Audits and Vendor Certification. Perform
training of the Technicians, Executives / Officers and Managers of all functions at Glenmark Pharma's
location. Responsible for hosting and handling international regulatory auditors.
08/2003
-
10/2004
Quality Assurance Officer
Dr Reddy's Laboratories Ltd.
To co-ordinate for Preparation, Review, Revision and Approval of SOPs of all functions, viz. QA, QC,
Production, Warehouse, Engineering and P&A. Planning Organising, Leading and performing Selfinspection.
Follow-up for the Preventive and Corrective actions for observed Non-conformances Coordinate
for Qualification (DQ/IQ/OQ/PQ) of Equipment (Sterile and solid oral), Instruments and
Utilities for all Oral formulation Specialised in Commissioning and qualification of Utilities (HVAC,
Water system, Compress Air and Nitrogen), Computer systems and processes. Preparation of Apex
documents like Site Master File, QA Manual, Training Manual and VMP. Overall performance of
cleaning validation program via CVMP to reports and Process Validation. Third-party audits, vendor
Audits and vendor certification. Training of the Technicians, Executives/Officers and Managers of all
functions at all location. Responsible for hosting and handling international regulatory auditors.
Production, Warehouse, Engineering and P&A. Planning Organising, Leading and performing Selfinspection.
Follow-up for the Preventive and Corrective actions for observed Non-conformances Coordinate
for Qualification (DQ/IQ/OQ/PQ) of Equipment (Sterile and solid oral), Instruments and
Utilities for all Oral formulation Specialised in Commissioning and qualification of Utilities (HVAC,
Water system, Compress Air and Nitrogen), Computer systems and processes. Preparation of Apex
documents like Site Master File, QA Manual, Training Manual and VMP. Overall performance of
cleaning validation program via CVMP to reports and Process Validation. Third-party audits, vendor
Audits and vendor certification. Training of the Technicians, Executives/Officers and Managers of all
functions at all location. Responsible for hosting and handling international regulatory auditors.
11/2001
-
07/2003
QA Officer
Abbott Ltd.
Responsible for Validation and Quality Assurance of the Goa Site and was also responsible for the
Quality Management system at the Third Party manufacturing site Solid oral and Sterile
Manufacturing in India. Implementation of the Quality Management System as per cGMP and
International requirements at all Manufacturing, Testing and Distribution levels. To interact with
external auditors, and to ensure compliance with any Inspectional Observations. To co-ordinate for
Preparation, Review, Revision and Approval of SOPs of all functions, viz. QA, QC, Production,
Warehouse, Engineering and P&A. Planning Organising, Leading and performing Self-inspection.
Follow-up for the Preventive and Corrective actions for observed Non-conformances. Responsible for
Batch Record review, Process validation, change control, Deviations and in-process monitoring in
manufacturing operations. Review and closing of Batch Manufacturing Records. Core member for
the investigation of the failures on the shop floor. Conduct training programs for the new associates
and periodic updates on SOP's, unplanned deviations, and training to the technicians.
Quality Management system at the Third Party manufacturing site Solid oral and Sterile
Manufacturing in India. Implementation of the Quality Management System as per cGMP and
International requirements at all Manufacturing, Testing and Distribution levels. To interact with
external auditors, and to ensure compliance with any Inspectional Observations. To co-ordinate for
Preparation, Review, Revision and Approval of SOPs of all functions, viz. QA, QC, Production,
Warehouse, Engineering and P&A. Planning Organising, Leading and performing Self-inspection.
Follow-up for the Preventive and Corrective actions for observed Non-conformances. Responsible for
Batch Record review, Process validation, change control, Deviations and in-process monitoring in
manufacturing operations. Review and closing of Batch Manufacturing Records. Core member for
the investigation of the failures on the shop floor. Conduct training programs for the new associates
and periodic updates on SOP's, unplanned deviations, and training to the technicians.
10/2000
-
12/2001
Trainee Chemist
Lupin Limited
Supervisor for production of Sterile manufacturing (Dry Powder Injection and liquid Ampoule) at
Lupin Ltd. Supervision of Day-to-Day activities related to Production, Dispensing, batch
Manufacturing, documentation as per cGMP. Weekly and daily workforce and production planning.
In-process control checks. Rejection controls to improve the Yields. Preparation of Batch
Manufacturing Record. Maintaining shop floor Documents and cGMP records. Responsible for
Production and utility and sterile equipment Qualification and validation activities. Calibration of
instruments and equipment.
End of the Document .
Lupin Ltd. Supervision of Day-to-Day activities related to Production, Dispensing, batch
Manufacturing, documentation as per cGMP. Weekly and daily workforce and production planning.
In-process control checks. Rejection controls to improve the Yields. Preparation of Batch
Manufacturing Record. Maintaining shop floor Documents and cGMP records. Responsible for
Production and utility and sterile equipment Qualification and validation activities. Calibration of
instruments and equipment.
End of the Document .
Local Availability
Only available in these countries:
United Kingdom
Readily available to travel around the globe
