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Job offer: Support AQ IT Validation & Data Integrity H / F

GMSD, a global leader in the pharmaceutical industry, is present with a diversified and innovative portfolio in the markets for prescription products, vaccines and animal health products. For its Miribel site in Riom (63) the company is looking for an AQ Support Validation & Data Integrity H / F.

General information

 business
Company 

Pharmaceutical
MSD

One of the world's leading pharmaceutical companies, is present with a diversified and innovative portfolio in the markets for prescription products, vaccines and animal health products. Today, we are building a new model of a pharmaceutical company - a company committed to creating a future that will improve everyone's health.

Our ability to excel is linked to integrity, knowledge, imagination, competence, diversity and teamwork that you can demonstrate. Around our values, we aim to create an environment of mutual respect, encouragement and teamwork. Integrated with our global team, you will have the opportunity to collaborate with talented and committed colleagues while having the opportunity to develop and diversify your career.

Job Description

Location
Country
Regions
Workplace
Job Title
Contract
Activity rate
Mission 

























Europe
France
Auvergne - Rhône Alpes
Mirabel-Riom (63)
Galenic development manager (injectable) H / F
CDN 8 month
Full-time
Provide Quality Assurance tracking and audits of all IT validation projects (local or global) to ensure compliance with applicable regulatory requirements, policies and procedures.
Assist periodic review activities of local or global systems used in any regulatory activity.


Role and responsibilities :
  • Communicate any quality or compliance risk to its head of mission
  • Provide Quality Assurance tracking of all computer validation projects to ensure regulatory compliance and assist in the development and / or review of project validation documents
  • Assist in the development and maintenance of a computer validation principles training program (SDLC v.2) and regulatory requirements for computer validation, maintenance and use of computerized systems
  • Assist in developing and maintaining a single inventory of computerized systems used in operations subject to GMP and Data Integrity requirements as well as their compliance status
  • Review validation plans, test results, and validation reports for compliance with regulatory requirements. Prepare project follow-up reviews describing deficiencies and deviations from regulatory and procedural requirements and ensure their resolutions before systems are commissioned
  • Assist in the review of the periodic review reports of the computerized systems in collaboration with the technical support (MMD IT, MMD Automation) in charge of their planning
  • Provide "compliance" support to operational staff on regulatory requirements for computerized systems in terms of validation, requirements development and user requirements, test strategies, and associated documentary requirements
  • Maintain up-to-date knowledge and skills on regulatory requirements, practices and procedures and pass them on to site EMS staff
  • Conduct any other associated tasks as assigned by the mission leader.

PROFILE
• Bac + 4 / 5 in a scientific and / or computing discipline
• Experience of at least 5 years in pharmaceutical, bio-technology or bio-industry
• Field knowledge of computer validation requirements would be preferable (GAMP, 21 CFR PART 11), however, SDLC training (including 21 CFR Part 11 requirements) will be provided, if applicable.
• High leadership, communication skills
•English proficiency



candidate criteria

Minimum level of education required

Diploma

Science specialty

Minimum Experience Level

required

Languages
Bac + 4 / 5 Bac +


4-Master / Master / DEA / DESS // Engineer

Science and / or Computing

5 years or more



English (Maitrise)


Thank you for applying to the offer via the following link:

https://taleo.msd.com/careersection/msd_external_career_section/jobdetail.ftl?job=REG002834&lang=fr_FR&sns_id=mailto#.WR7n2l64qAU

 

 

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The A3P Association is a major player in the pharmaceutical and biotechnology industry.
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It now has over 1700 members who share their technical experience, scientific and regulatory.

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