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Quality Compliance Manager

Published on 02.12.2021

Company

Website : https://www.gsk.com/en-gb/
Industries :
Pharmaceutical industry
Services other
Health, pharmacy, hospitals, medical equipment
Job ads : See our Job Ads
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. read more

Job Ad & Profile Description

Position : Quality Compliance Manager

Job Purpose

Provides leadership within Quality Systems functional area focusing on building and strengthening deployment of QMS, CCR, and CAPA. Lead internal/external audits and to host and reply for toll manufacturers, regulatory audits

To work in partnership with the business to define capability priorities and lead the execution of agreed L&D projects across the full end to end learning cycle with the aim of equipping employees with the specific capabilities that enable them to add value and drive competitive advantage for the organization.

The scope of the role is focused on delivering small to medium scale L&D projects that support a specific functional area or site. This is most likely to have single country impact but may be multiple.

Key Responsibilities

  • Internal audit and self-inspection Process Manager.
  • Act as site system Lead for Trackwise software for CAPA Management to ensure effective CAPA closure in timely manner along with Implement CAPA effectiveness program and sustain deliverables.
  • Act as Site inspection readiness Lead hosting audits
  • Handle and manage site quality issues related to site compliance performance.
  • Ensure local and global regulatory conformance and alignment.
  • Leading GSK-QMS policies deployment and assure their effective implementation.
  • Follow up of key policies handling (Deviation handling, customer complaints, Recall, Sterile operations, and validation).
  • Participate in annual Quality strategy and objectives.
  • Provide oversight and governance to ensure quality standards are effectively implemented in manufacturing sites across GSK Network.
  • Ensure proper lifecycle management of documents
  • Act as change control Process Owner for the planned changes and review their effective implementation.
  • Develop in partnership with TL&OD, Site Quality head & SD the required L&D strategy that clearly defines capability priorities aligned to the business agenda.
Required profile for job ad : Quality Compliance Manager

Basic Requirements

  •   Bachelor’s degree in pharmaceutical sciences.
  • 8 Years in pharmaceutical field with strong Knowledge on Quality Management Systems, Auditing Process and CAPA management system.

Essential Skills And Abilities

  • Fluent English language skills (speaking and writing).
  • Quality systems deep knowledge.
  • Additional certificate in management of Quality systems (TQM, CQM, etc).
  • Strong knowledge and experience of the End to End (E2E) learning process i.e., learning needs assessment, program design, delivery, learning evaluation and assessment.
  • Proven ability to interpret customer needs and translate these into a coherent programme of work.
  • Track record of project management skills and expertise across medium to large scale projects.
  • Experience of leading ‘development’ initiatives i.e., training, coaching, learning initiatives.
  • Strong interpersonal, communication and presentation skills.
  • Financial acumen.
  • The ability to work successfully in a fast-paced environment with the need to manage constant change. The ability to deal with ambiguity – ready to change gears and plans quickly.
  • Ability to build relationships quickly and credibly.
  • Experience of working within a complex, matrixed environment.
Job criteria for job ad : Quality Compliance Manager
Job category :
Management
Production, maintenance, quality
R&D, project management
Industries :
Health, pharmacy, hospitals, medical equipment
Pharmaceutical industry
Services other
Employment type :
Permanent contract
Region :
6th of October City - Alexandria - Arish - Aswan - Asyut - Banha - Beni Suef - Cairo - Damanhur - Damietta - El-Tor - Faiyum - Giza - Helwan - Hurghada - Ismailia - Kafr el-Sheikh - Kharga - Luxor - Mansura - Marsa Matruh - Minya - Port Said - Qena - Shibin el-Kom - Sohag - Suez - Tanta - Zagazig
Experience level :
5 to 10 years
Educational level :
Bachelor
Number of Position(s) : 5

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