Post by ncwebcenter on Aug 20, 2009 0:05:36 GMT -5
Quality Audit Manager
Requisition ID: 55133
Position: Full-Time Regular
Open date: Aug 18, 2009 3:12:37 PM
Functional area: Quality and Validation
Location: Asia Pac / MENA /SSA / Europe, Other and International
Grade level: D1-C4
Basic qualifications:
Science graduate, equivalent degree and or experience in the pharmaceutical industry in a cGMP regulated environment.
• Broad based familiarity experience in QA, QC, Manufacturing, Engineering and Projects with an area of specialisation.
• Familiarity with both food, cosmetics, secondary and primary pharmaceutical manufacturing.
• Knowledge of best practice world-wide cGMPs, regulatory requirements, standards and quality management systems.
• Knowledge of the pharmaceutical industry, analytical and manufacturing technologies, engineering practices, validation, cGMP compliance and risk management.
• Communicate within constraints of language and custom in different cultures.
• Setting and achievement of objectives without direct line management authority.
• Required to work both alone and with unfamiliar teams in challenging and complex environments under time constraints.
• Required to retain overall effectiveness during extended absences from office location. Travel, including overseas travel, may average 30-40% of the time, at times on short notice.
• Required to communicate with and influence all levels of internal and external organisations including senior management.
• Ability or capability to plan and lead complex audits and report technical details in a simple and concise manner.
Preferred qualifications:
• Experience in a manufacturing, quality and/or auditing role.
• Experience preparing sites for regulatory inspections and providing advice and consultation.
• Experience working with sites during regulatory inspections while regulatory is on site.
• New Product Introduction and Due Diligence experience.
Details:
Details:
The Manufacturing Internal Audit department exists to provide independent quality and compliance auditing across GSK, including all Sites within Global Manufacturing & Supply and GSK Biologicals, R&D, Commercial Marketing Companies, and all Third Party Contractors.
The Manufacturing Internal Audit department supports the Centralised GSK Assurance Capability under the Company Secretary and Compliance Officer to develop and manage the consolidated GSK Risk and Audit universes and integrate all aspects of assurance – risk, compliance and audit. This includes the development of the new GSK Annual Strategic Assurance Plan and subsequent reports for the Audit Committee and CET.
This role is part of a matrix of audit managers and reports directly to an Audit Director with responsibility to assure the compliance of assigned parts of the GSK manufacturing and supply network with POL GSK 500 and the GSK Quality Management System for the manufacture and supply of products.
Key Responsibilities
The primary purpose of this job is to lead and manage audits of assigned manufacturing sites, commercial companies, contractors or business processes, and to produce audit reports that ensure that senior management is appraised of the identified risks and that appropriate corrective action plans are implemented.
In addition:
• Manage the interface with auditees (Typically: Site Directors & Site Quality Directors, Heads of Support Functions, General & Quality Mgr of Commercial Companies, Manufacturing & Quality Directors of Contractors).
• Update assigned Quality Risk Model elements and maintain Auditee Profiles.
• Carry out investigations into serious incidents and contribute to prevention of further occurrence across GSK.
• Communicate learning points through Quality Alerts and Quality Updates.
• Promote early visibility of regulatory issues and GSK responses.
• Support efforts to positively influence regulators on matters which impact GSK.
• Update assigned Global QMS Documents and Audit function SOPs.
• The training and coaching of other shared service auditors (by example during audits or through peer review of reports).
• Support of the Auditor Certification process (either as a trainer or an interviewer).
Typical work output will involve:
• Audits of manufacturing sites, from small single market supply sites up to large, complex, highly regulated global supply sites supporting >£1000m sales.
• The preparation of sites for regulatory inspections including pre-Approval Inspections.
• Due diligence evaluations of prospective contractors or suppliers of critical products.
• Audits of cross functional business processes.
• Audits and assessments of progress against risk mitigation plans or regulatory citation commitments.
Closing date for applications: September 2nd 2009
Please note that if you have previously applied for requisition number 54262, you do not need to submit an additional application for this role.
When applying for this role, please use the 'cover letter' of the on-line application to clearly describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter will be used to assess your application.
Thank you for your interest in this opportunity.
Any UK or European GMS site can potentially be considered as a base location, subject to site approval and suitability. Please indicate location preference within your application.
To apply, please send resume to info@ncwebcenter.com with the subject line "GSK - Quality Audit Manager".
Requisition ID: 55133
Position: Full-Time Regular
Open date: Aug 18, 2009 3:12:37 PM
Functional area: Quality and Validation
Location: Asia Pac / MENA /SSA / Europe, Other and International
Grade level: D1-C4
Basic qualifications:
Science graduate, equivalent degree and or experience in the pharmaceutical industry in a cGMP regulated environment.
• Broad based familiarity experience in QA, QC, Manufacturing, Engineering and Projects with an area of specialisation.
• Familiarity with both food, cosmetics, secondary and primary pharmaceutical manufacturing.
• Knowledge of best practice world-wide cGMPs, regulatory requirements, standards and quality management systems.
• Knowledge of the pharmaceutical industry, analytical and manufacturing technologies, engineering practices, validation, cGMP compliance and risk management.
• Communicate within constraints of language and custom in different cultures.
• Setting and achievement of objectives without direct line management authority.
• Required to work both alone and with unfamiliar teams in challenging and complex environments under time constraints.
• Required to retain overall effectiveness during extended absences from office location. Travel, including overseas travel, may average 30-40% of the time, at times on short notice.
• Required to communicate with and influence all levels of internal and external organisations including senior management.
• Ability or capability to plan and lead complex audits and report technical details in a simple and concise manner.
Preferred qualifications:
• Experience in a manufacturing, quality and/or auditing role.
• Experience preparing sites for regulatory inspections and providing advice and consultation.
• Experience working with sites during regulatory inspections while regulatory is on site.
• New Product Introduction and Due Diligence experience.
Details:
Details:
The Manufacturing Internal Audit department exists to provide independent quality and compliance auditing across GSK, including all Sites within Global Manufacturing & Supply and GSK Biologicals, R&D, Commercial Marketing Companies, and all Third Party Contractors.
The Manufacturing Internal Audit department supports the Centralised GSK Assurance Capability under the Company Secretary and Compliance Officer to develop and manage the consolidated GSK Risk and Audit universes and integrate all aspects of assurance – risk, compliance and audit. This includes the development of the new GSK Annual Strategic Assurance Plan and subsequent reports for the Audit Committee and CET.
This role is part of a matrix of audit managers and reports directly to an Audit Director with responsibility to assure the compliance of assigned parts of the GSK manufacturing and supply network with POL GSK 500 and the GSK Quality Management System for the manufacture and supply of products.
Key Responsibilities
The primary purpose of this job is to lead and manage audits of assigned manufacturing sites, commercial companies, contractors or business processes, and to produce audit reports that ensure that senior management is appraised of the identified risks and that appropriate corrective action plans are implemented.
In addition:
• Manage the interface with auditees (Typically: Site Directors & Site Quality Directors, Heads of Support Functions, General & Quality Mgr of Commercial Companies, Manufacturing & Quality Directors of Contractors).
• Update assigned Quality Risk Model elements and maintain Auditee Profiles.
• Carry out investigations into serious incidents and contribute to prevention of further occurrence across GSK.
• Communicate learning points through Quality Alerts and Quality Updates.
• Promote early visibility of regulatory issues and GSK responses.
• Support efforts to positively influence regulators on matters which impact GSK.
• Update assigned Global QMS Documents and Audit function SOPs.
• The training and coaching of other shared service auditors (by example during audits or through peer review of reports).
• Support of the Auditor Certification process (either as a trainer or an interviewer).
Typical work output will involve:
• Audits of manufacturing sites, from small single market supply sites up to large, complex, highly regulated global supply sites supporting >£1000m sales.
• The preparation of sites for regulatory inspections including pre-Approval Inspections.
• Due diligence evaluations of prospective contractors or suppliers of critical products.
• Audits of cross functional business processes.
• Audits and assessments of progress against risk mitigation plans or regulatory citation commitments.
Closing date for applications: September 2nd 2009
Please note that if you have previously applied for requisition number 54262, you do not need to submit an additional application for this role.
When applying for this role, please use the 'cover letter' of the on-line application to clearly describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter will be used to assess your application.
Thank you for your interest in this opportunity.
Any UK or European GMS site can potentially be considered as a base location, subject to site approval and suitability. Please indicate location preference within your application.
To apply, please send resume to info@ncwebcenter.com with the subject line "GSK - Quality Audit Manager".