Ad, Learning Systems Compliance

2 weeks ago

Hyderabad Telangana, India Sandoz Full time

Job ID 379942BR
Jul 26, 2023
India
**Job Description**:
2023 will potentially see Sandoz become a standalone organization Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, purpose-driven organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally

Together we will shape the future of Sandozare you ready to make a difference?

**Position Purpose**:
This position ensures that all the Learning Systems are operationally meeting all compliance, legal and audit-readiness requirements, maintained in a validated state and ensuring strict system adherence to both industry and company specific compliance requirements through change management, product releases of the vendor as well as internal projects. This role reports to the Business & System Owner, Global Director Learning Platforms, and partners closely with the Global Process Owner of Learning, Service Integration, Service Delivery, IT operations, Quality operations, and Program team. The role holder will also provide guidance in solving point-in-time challenges in case of major impact and partner with internal collaborators to increase the effective use and adoption of the Learning platform from GxP point of view.

**Your Key Responsibilities**:
Your responsibilities include, but not limited to
- GxP Systems

a. Assist in developing and documenting processes to improve efficiency for Learning systems & tools, as may be applicable in coordination with the Global Process Owner for Learning. Supports compliance with legal framework, SOX requirements, and Sandoz specific policies & guidelines. Manage all system life cycle documents in partnership with PQM and OQM.
b. Liaise with vendor quality for getting the required system validation documentations and maintenance of quality assurance agreement.
c. User access management
- review and approval of Learning and System admin access requests after ensuring the individual meet the defined requirements.
d. Serve as the Subject Matter Expert on GxP for Learning systems.
e. Ensure that impact assessments of any deviations that impact the System Owner’s area of responsibility, are accurate and comprehensive and that CAPA are appropriate.
f. Participate in Risk Assessment and advise on its mitigation / reduction.
h. Contribute to regular meetings with internal partners and make recommendations to provide continued improvement with processes, workflows, and system configuration.
i. Ensure, together with the Business & System Owner, that the system operates in compliance with all applicable internal and external regulations, policies, and guidelines, with the objective of maintaining the accuracy and security of all data residing within systems in scope.
j. Design and manage audit / inspection readiness strategy, governance, and process.
k. Serve as a liaison to all audit, inspection, and legal cases requests.
l. Monitor audit / inspection calendar and plan appropriate support in coordination with Global Quality and P&O Analytics & GPO Learning.
m. Advice on necessary procedures as provided to implement CAPA, system related deviations, quality assessments and assess the implementation.
n. Audit / Organize regular quality checks to ensure system compliance.
o. Identify process / system risks, advise, and develop solutions to mitigate risks, within organizational constraints.
p. Perform, review, and advise Business System Owner on periodic review activities related to GxP validated state for system.
q. Ensure documentation, processes and standards are maintained or created for the Learning platform(s).
r. Advice on training requirements within Learning CoE and extended P&O Technology executing validation deliverables and supporting the Learning systems as per their assigned responsibilities.
- Non GxP Systems

A. Ensure system compliance of Non-GxP Learning systems in scope, as defined by relevant policies and procedures
B. Ensure system integrity is maintained during projects, major / minor releases as well as during projects
- Deputy of Business System Owner

A. Review, approve and sign-off business processes, User Requirements, design, and structure / data definitions for GxP and non GxP systems in scope
B. Review and approve all validation deliverables / lifecycle deliverables defined as per Validation Master plan
D. Serve as a liaison to Learning System(s) quality assurance team in case of GxP quality related matter
Performs other tasks as assigned by Line Manager.

Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Minimum Requirements

**What you’ll bring to the role**:
**Essential Requirements**:

- Bachelor’s degree required. Human Resources discipline preferred, with In-depth knowledge and 5+ years o

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