Head of Quality Assurance
LM Manufacturing Limited
Skills
Qualified Person under permanent provisions of Directive 2001/83/EC.
*Conducting Global GMP, GDP audits and across other GXPs including 'For Cause Audits' for various clients.
*Support Global quality where appropriate through performing GXP Audits.
*Analyse audit results in accordance with client requirements and Relevant guidelines, diagnose quality critical issues, assess Corrective and preventive actions before successful closure of audits.
*Risk assessment and approval of suppliers and processes from quality perspective and to ensure delivery of a regulatory compliant audit program to fulfil requirements of business and continuity.
*Provide Executive summary and key critical areas that could impact Quality, Safety and Efficacy of the Products in scope of audits
*Conducting Global GMP, GDP audits and across other GXPs including 'For Cause Audits' for various clients.
*Support Global quality where appropriate through performing GXP Audits.
*Analyse audit results in accordance with client requirements and Relevant guidelines, diagnose quality critical issues, assess Corrective and preventive actions before successful closure of audits.
*Risk assessment and approval of suppliers and processes from quality perspective and to ensure delivery of a regulatory compliant audit program to fulfil requirements of business and continuity.
*Provide Executive summary and key critical areas that could impact Quality, Safety and Efficacy of the Products in scope of audits
Project history
09/2015
-
03/2017
LM Manufacturing Limited, Weedon Bec, NorthamptonNN74PP (United Kingdom)
*Building a team of 40 personnel on site with various technical capabilities in Quality Assurance,
Production, Warehouse, Quality Control, Engineering and Validation.
*Developing Quality management system on site in compliance with current EU guidelines for GMP, GDP
in-house Standard operating procedures, core documents i.e. Site Master file, Quality manual, Site
validation masterplan etc.
* Auditing vendors of API, Primary packaging materials, Warehousing facility to assess suitability
with relevant Guidelines and approving them for use.
* Assisting Qualified Person (QP) in Quality Management System related issues at Site. meeting the
statutory/Regulatory requirement.
*Designing /Commissioning and monitoring the internal quality audits, escalating it to Senior
management as part of periodic Quality Review and identify the risks associated with the facility
and products.
*Identifying to impart/arrange training on various GMP topics like Cleaning Validation, Impurity
profile, Method validation, Audit & compliance, Quality Risk assessment etc. and arrange external
training whenever required.
*Leading and managing the strategic and operational performance of the Quality department, ensuring
the successful delivery of business strategy, Key Performance Indicators (KPIs) and objectives,
whilst adhering to regulatory compliance and achieving commercial success. Preparing, reviewing and
approving Technical and Quality Agreements with all service providers.
*Acting as nominated person for manufacturing and storage of controlled drugs in accordance with
Home Office regulations.
*Ensuring good relations and communications with all members of the team and in a timely manner to
internal and external customers.
*Building a team of 40 personnel on site with various technical capabilities in Quality Assurance,
Production, Warehouse, Quality Control, Engineering and Validation.
*Developing Quality management system on site in compliance with current EU guidelines for GMP, GDP
in-house Standard operating procedures, core documents i.e. Site Master file, Quality manual, Site
validation masterplan etc.
* Auditing vendors of API, Primary packaging materials, Warehousing facility to assess suitability
with relevant Guidelines and approving them for use.
* Assisting Qualified Person (QP) in Quality Management System related issues at Site. meeting the
statutory/Regulatory requirement.
*Designing /Commissioning and monitoring the internal quality audits, escalating it to Senior
management as part of periodic Quality Review and identify the risks associated with the facility
and products.
*Identifying to impart/arrange training on various GMP topics like Cleaning Validation, Impurity
profile, Method validation, Audit & compliance, Quality Risk assessment etc. and arrange external
training whenever required.
*Leading and managing the strategic and operational performance of the Quality department, ensuring
the successful delivery of business strategy, Key Performance Indicators (KPIs) and objectives,
whilst adhering to regulatory compliance and achieving commercial success. Preparing, reviewing and
approving Technical and Quality Agreements with all service providers.
*Acting as nominated person for manufacturing and storage of controlled drugs in accordance with
Home Office regulations.
*Ensuring good relations and communications with all members of the team and in a timely manner to
internal and external customers.
06/2015
-
09/2015
Quality Manager
GSK
GSK, Priory Street, Ware SG12 0 DJ (United Kingdom)
*QMS support for manufacturing operations.
*Help and support Qualified Persons (QPs) on site in Batch Card Review and
Manufacturing oversight and accountability and Pre-Audit inspection of the
manufacturing units
*QMS support for manufacturing operations.
*Help and support Qualified Persons (QPs) on site in Batch Card Review and
Manufacturing oversight and accountability and Pre-Audit inspection of the
manufacturing units
01/2013
-
03/2015
Quality Manager
Martindale Pharma
Martindale Pharma, Bampton Road, Romford, RM3 8UG(United Kingdom)
* Providing support to Qualified Persons to discharge their duties as defined in Article 51 of
directive
2001/83. EC. Also, involved in Vendor Audits for APIs and Primary packaging materials, Internal
Audits, decisions on temperature excursions for products exported, approval of documents, artworks
and specifications, contact point for QMS related issues i.e. Incidents, Change control, Deviations,
CAPA etc.
* Involved in batch card reviews and release process including pre-release transactions on SAP
system including Periodic Quality review.
* Providing support to Qualified Persons to discharge their duties as defined in Article 51 of
directive
2001/83. EC. Also, involved in Vendor Audits for APIs and Primary packaging materials, Internal
Audits, decisions on temperature excursions for products exported, approval of documents, artworks
and specifications, contact point for QMS related issues i.e. Incidents, Change control, Deviations,
CAPA etc.
* Involved in batch card reviews and release process including pre-release transactions on SAP
system including Periodic Quality review.
11/2011
-
10/2012
General Manager and Responsible person(RP)
Accord Healthcare
Accord Healthcare, Home Field Road, Haverhill CB98QP, UK, Haverhill (United Kingdom)
* To carry out all the activities as Site Head and Responsible person (RP) with direct reports from
functional heads from Production, Quality Control, Engineering and warehouse reporting into my
position. The total number of personnel at the site - 65.
* Involved in Warehousing and logistics functions as per c GMP /GDP guidelines including market
complaints and recalls.
* Annual budget compilation (Capex, Head count) for packaging and warehouse operations. To manage
costs in the budget and identify opportunities to reduce variance and timely implementation of
projects and Capex items.
* To carry out all the activities as Site Head and Responsible person (RP) with direct reports from
functional heads from Production, Quality Control, Engineering and warehouse reporting into my
position. The total number of personnel at the site - 65.
* Involved in Warehousing and logistics functions as per c GMP /GDP guidelines including market
complaints and recalls.
* Annual budget compilation (Capex, Head count) for packaging and warehouse operations. To manage
costs in the budget and identify opportunities to reduce variance and timely implementation of
projects and Capex items.
03/2010
-
10/2011
Group Quality Control/Quality Assurance Manager group of pharmaceutical companies
Cambridge Healthcare, Packpharm Ltd, Torbet Laboratories and Typharm Ltd.
Healthcare, Packpharm Ltd, Torbet Laboratories and Typharm Ltd.),14 D, Wendover Road, Rack heath
Industrial Estate, Norwich NR13 6LH Norwich (United Kingdom)
Quality Management System (QMS) related functions of the group of companies, working in close
coordination with 'Qualified Person' on,
* Manufacturing of batches complying with marketing authorisation.
* Validation of all the manufacturing and testing procedures.
* Documentation, Batch release and Annual Product Quality Review (APQR) * Vendor audits.
Industrial Estate, Norwich NR13 6LH Norwich (United Kingdom)
Quality Management System (QMS) related functions of the group of companies, working in close
coordination with 'Qualified Person' on,
* Manufacturing of batches complying with marketing authorisation.
* Validation of all the manufacturing and testing procedures.
* Documentation, Batch release and Annual Product Quality Review (APQR) * Vendor audits.
07/2009
-
12/2009
Site Head -Quality Assurance
Accord Healthcare UK
Accord Healthcare UK, Home Field Road, Haverhill CB 9 8QP (United Kingdom)
* Implementation of Quality Management Systems in accordance with cGMP.
* Preparation and checking of all relevant documents, authorization, control and distribution.
* Necessary controls on process and validations.
* Ensuring that the batches were produced and controlled in accordance with marketing authorization
* That the products were stored distributed and subsequently handled appropriately so that the
quality was maintained throughout the shelf life.
* Proper procedures for self-inspection, quality audits to regularly appraise the effectiveness and
applicability of QMS systems.
* Implementation of Quality Management Systems in accordance with cGMP.
* Preparation and checking of all relevant documents, authorization, control and distribution.
* Necessary controls on process and validations.
* Ensuring that the batches were produced and controlled in accordance with marketing authorization
* That the products were stored distributed and subsequently handled appropriately so that the
quality was maintained throughout the shelf life.
* Proper procedures for self-inspection, quality audits to regularly appraise the effectiveness and
applicability of QMS systems.
11/2007
-
12/2008
Production Manager
Nestor UK Limited
Nestor UK Limited, Chiswick Avenue, Mildenhall IP28 7AX (United Kingdom)
* Worked in MHRA approved plant in England with facilities of manufacturing and
packing tablets, capsules and semisolid. The responsibility in this assignment
included all planning, production, and packing activities to meet the timelines
and stipulated Quality aspects from the contract Giver.
* Worked in MHRA approved plant in England with facilities of manufacturing and
packing tablets, capsules and semisolid. The responsibility in this assignment
included all planning, production, and packing activities to meet the timelines
and stipulated Quality aspects from the contract Giver.
11/2003
-
10/2007
Production Manager
Norbrook Laboratories
Norbrook Laboratories, Station Works, Newry, BT 35 6JP N. Ireland, (United Kingdom)
* Worked in USFDA approved plant of liquid injectable where the number of direct reports to my
position were 20.I was also involved in starting up a new human medicines facility for tablets,
capsules and powders. The salient features of this assignment were Controlled Drugs manufacturing,
Executing validation protocols, process development training and documentation as per cGMP, MHRA and
USFDA.
* Worked in USFDA approved plant of liquid injectable where the number of direct reports to my
position were 20.I was also involved in starting up a new human medicines facility for tablets,
capsules and powders. The salient features of this assignment were Controlled Drugs manufacturing,
Executing validation protocols, process development training and documentation as per cGMP, MHRA and
USFDA.
02/1996
-
09/2003
Senior Manager-Operations
Morepen Laboratories Limited
Morepen Laboratories Limited, Unit III, Parwanoo Himanchal Pradesh (India)
* Responsible for coordinating & guiding various agencies from conceptual stage to actual
manufacturing operations of tablets and capsules. The active involvement included, Procurement
installation and validation of plant and machinery, Training, Documentation, launch of new products,
Coordinating Contract and Third-party manufacturing and other operation related activities.
* Responsible for coordinating & guiding various agencies from conceptual stage to actual
manufacturing operations of tablets and capsules. The active involvement included, Procurement
installation and validation of plant and machinery, Training, Documentation, launch of new products,
Coordinating Contract and Third-party manufacturing and other operation related activities.
08/1990
-
01/1996
Assistant Manager
Max India Limited
Max India Limited, Dr. Zha Marg, Okhla, New Delhi (India)
* Responsible for liquid parenteral department for producing injectable for M/S Ranbaxy
Laboratories, New Delhi, India. Also, responsible for Contract manufacturing and Third-party
manufacturing including Auditing the facilities for suitability.
* Responsible for liquid parenteral department for producing injectable for M/S Ranbaxy
Laboratories, New Delhi, India. Also, responsible for Contract manufacturing and Third-party
manufacturing including Auditing the facilities for suitability.
05/1987
-
06/1990
Practicing Pharmacist
Behzad Medical Est.
09/1986
-
01/1987
Production Officer
Euphoric Limited
Euphoric Limited, Nehru Place New Delhi (India)
* Responsible for production of tablets capsules and dry syrups co-coordinating with marketing for
national product requirements.
* Responsible for production of tablets capsules and dry syrups co-coordinating with marketing for
national product requirements.
11/1983
-
08/1986
Production Supervisor
Ranbaxy Limited
Ranbaxy Limited, Dr. Zha Marg, Okhla , New Delhi (India)
* Manufacturing and packing of tablets, capsules and dry syrups,
* Manufacturing and packing of tablets, capsules and dry syrups,
Local Availability
Only available in these countries:
United Kingdom
Flexible Globally
