Manager - Regulatory Affairs
Manager - Regulatory Affairs
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Job Description
Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125000 people across 30 countries are driven by our innate curiosity entrepreneurial agility and desire to create lasting value for clients. Powered by our purpose the relentless pursuit of a world that works better for people we serve and transform leading enterprises including the Fortune Global 500 with our deep business and industry knowledge digital operations services and expertise in data technology and AI.
Inviting applications for the role of Manager - Training and SoP Author Lead Regulatory
We are looking for a Training and SoP Author Specialist with experience in the Life Sciences pharmaceutical industry to ensure compliance with regulatory requirements including 21 CFR Part 11 GxP and Annex 11. The ideal candidate should have expertise in Regulatory Information Management applications with a strong understanding of Veeva Vault RIMS being a plus.
Responsibilities
Able to understand the basics of a new system and process the clients way of working and the training strategy
Develop and deliver training materials per clients requirements while ensuring compliance
To be able to handle various platforms namely Learning Management Systems (Veeva Vault Training Cornerstone OnDemand) for training delivery content development tools (Articulate 360 Adobe Captivate) SOP and Document Management Systems (Documentum) Assessment and Evaluation tools (Google Forms & Microsoft Forms) Virtual Training and Collaboration Tools (Microsoft Teams Zoom Webex Training)
To be able to collect and document the training and SOP aspects discussed in the focus topics
Assign content to the correct training module (functional vs. process training vs. SOP)
Collaborate with different departments to identify training needs gaps and raise questions in case of unclarities
Update training materials as per the feedback received from SMEs
Develop review and update SOPs to comply with regulatory standards
Develop Work Instructions and Handouts as per industry best practices
Ensure training and SOPs are written clearly and in compliance with the language
Manage the SOP lifecycle version control approvals and periodic reviews
Ensure all users are trained on the new and updated training materials & SOP in timely manner
Knowledge of GMP GCP GLP and Pharmaceutical Regulation (EMA ICH FDA etc.) is required
Strong experience with LMS RIMS and DMS systems is necessary.
General tasks:
Understand new systems processes clients way of working and training strategy.
Develop and deliver compliant training materials per client requirements.
Handle platforms for training delivery content development SOP and document management assessment and evaluation and virtual training and collaboration.
Document training and SOP aspects discussed in focus topics.
Experience:
Bachelors or Masters degree in Pharmaceutical Computer Science IT Engineering or a related field.
Moe experience in Computer System Validation (CSV) in the pharmaceutical biotech or medical device industry.
Strong knowledge of GxP 21 CFR Part 11 GAMP 5 Data Integrity and Annex 11.
Experience in validating SaaS applications used in the pharmaceutical industry.
Familiarity with Veeva Vault RIMS QualityDocs or Submissions Archive is a plus.
Excellent documentation skills and experience with validation lifecycle documentation.
Ability to work independently and collaborate with cross-functional teams.
Qualification:
Atleast Bachelors degree required in for Pharmaceutical: science engineering or related field (advanced degree preferred).
Veeva Vault RIM certification is a plus.
Experience working in an Agile/Scrum environment
Language: English
Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race color religion or belief sex age national origin citizenship status marital status military/veteran status genetic information sexual orientation gender identity physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values diversity and inclusion respect and integrity customer focus and innovation. For more information visit . Follow us on Twitter Facebook LinkedIn and YouTube.
Furthermore please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a starter kit paying to apply or purchasing equipment or training.
Required Experience:
Manager
Employment Type
Full-Time
