e-Compliance Manager
Stiefel Laboratories, Inc
Nyon, Switzerland
vor 4 Tg.

Your Responsibilities :

As the Quality and Compliance Authority within their respective business unit they shall

  • act as a single point of contact (SPOC) for the procurement of computerised systems providing subject matter review and approval of key validation documents for the full lifecycle from implementation through to retirement for their business unit
  • follow up on activities which impact the validated status of computerised systems within their business unit
  • provide the necessary subject matter support for audit types in their business unit. Audits may include but not be limited to regulatory, supplier and internal assessments that impact the computerised systems
  • maintain customer service relations and develop and sustain professional relationships that reflect commitment to GSK shared values.
  • Foster communication across the CH e-Compliance team

  • ensure that the justification for validating computerised systems is documented and independently reviewed and approved
  • assist with global and site compliance and data integrity initiatives (assessment, programme, reviews, etc.)
  • As Subject Matter Expert (SME) for computer systems validation within their respective business unit they

  • shall support the eCompliance and Data Integrity Lead with the creation and review of quality related procedures and material which impact their business unit
  • provide subject matter support to System Owners, Service Providers and vendors within their business unit and maintain the System Register
  • work independently by determining and pursuing courses of action to obtain desired functional and business objectives
  • Support Inspection Readiness preparation with close collaboration with Audit Co-ordinator(s); providing support for follow up and or remediation actions related to regulatory inspections
  • Basic qualifications :

    Bachelor of Science preferably in Computer Science, IT, Chemical Engineering, Automation, Engineering Pharmacy, Biology, or related technical field or significant professional experience

    Profound knowledge in computerised systems validation (CSV) and electronic data which impact cGMPs, GLP, GCP, GDP, EU Annex 11, Annex 15 and Code of Federal Regulations.

    and in Data Integrity within CSV

    Familiar with the validation and maintenance of Process and Distributed Control Systems, Laboratory and Clinical Systems and or Software

    Good understanding of the key expectations of the guideline documents supplied by FDA & MHRA, PIC / S and ISPE(GAMP).

    Knowledge of :

  • Project Management
  • Software Supplier Audits
  • Software Development Lifecycle
  • Change Control, Deviation and CAPA Management
  • Preferred qualifications :

  • At least 5 years’ experience in the pharmaceutical industry with 3 years+ experience in either Quality Assurance, Quality Management, IT Compliance or equivalent.
  • Strong communication and negotiation skills (oral and written) and can negotiate and influence best practice’ through positive communication with system owners, third party support organizations such as Information Technology, Off Shore Support and complementary workers
  • Demonstrate a proficient and thorough knowledge of computer system validation (CSV) as defined by health authorities (FDA, EMEA, ICH), industry groups and the GSK QMS
  • Experience in international and multidisciplinary environments
  • Demonstrates attention to detail and organizational skills
  • Strong interpersonal skills
  • Willingness to travel
  • Results driven with a strong customer and quality focus
  • Ability to make decisions, evaluate risks and define and execute action plans
  • Ability to propose innovative solutions to solve problems
  • Fluent English required (written and spoken). Additional languages are a plus
  • Why GSK? :

    Our Consumer Healthcare business develops and markets products in Wellness, Oral health, Nutrition and Skin health categories.

    Our seven global power brands Otrivin, Panadol, parodontax, Poligrip, Sensodyne, Theraflu and Voltaren, include some of the most trusted

    and best-selling brands in the world.

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