09/06/2022 updated
KP
100 % available
Qualified person , GMP GDP Auditor
Bury St. Edmunds, United Kingdom
United Kingdom
Qualified Person, B.Pharmacy,AuditingCorrective and Preventive Action (CAPA)Risk AnalysisSafety Principles
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
Experience
Professional experience10+ years
Languages
EnglishFluent
Project history
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.
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
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.