Specialist - QPPV at SANDOZ INC

, , India -

Full Time

Start Date

Immediate

Expiry Date

16 Mar, 26

Salary

0.0

Posted On

16 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Databases, Employee Training, Filing Documents, Pharmacovigilance, Reporting, Safety Science

Industry

Pharmaceutical Manufacturing

Description

Job Description Summary Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape! QPPV Office Specialist is supports in developing, implementing, and performing monitoring activities designed to ensure compliance in accordance with Sandoz internal and worldwide regulatory timelines. Job Description Your Key Responsibilities: Your responsibilities include, but not limited to: Support the development, management and implementation of deviations and associated CAPAs and effectiveness checks across the Patient Safety organization and cross functionally. Support inspection and audit operations, including CAPA development, tracking and management, and act as CAPA coordinator in GxQEM system. Support PV performance oversight including creation and monitoring metrics, KPI, KQIs for PS and key vendors. Support QPPV in meeting legislative requirements. Support deviation management discussions and relevant activities Support the review of emerging worldwide regulations, impact assessments and process changes required to ensure ongoing compliance to global regulatory requirements. Business function responsible for allocated deviations and quality events, supporting PS throughout the deviation management processes. Support projects in the QPPV Office as required. Support in areas of the quality management system overview. Ensure that any potential risks or compliance issues identified through metrics data analysis and reports and are escalated in a timely manner. Support the development, implementation and dissemination of PS procedures including SOP management. Support with coordination activities in the QPPV office. Support with documentation and archival within the QPPV office What you’ll bring to the role: Essential Requirements: ≥ Two years of experience in drug development, including clinical safety, pharmacovigilance, and closely related areas of development Reasonable negotiation, conflict resolution, problem solving, communication (written and verbal) and presentation skills. Results driven, self-starter with proactive working style, committed and accountable, transparent working style also under pressure. Good planning, coordination and computer skills Why Sandoz? Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more! With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably. Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported! Join us! Skills Desired Databases, Employee Training, Filing Documents, Pharmacovigilance, Reporting, Safety Science Our Purpose here at Sandoz is pioneering access for patients. As the global leader in 'off-patent' high quality medicines, we are able to make medicine more affordable and accessible. Our broad global portfolio comprises of approximately 1,300 quality biosimilar and generic medicines, enabling us to provide more than 900 million patient treatments across 100+ countries per year, and while we are proud of this achievement, we have an ambition to do more! Powered by our talented and ambitious colleagues, who, in return for dedication and skills, experience a flexible, collaborative & inclusive culture where diversity of thought is welcomed and where personal growth is nurtured!

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Responsibilities

The role involves supporting the development and implementation of compliance monitoring activities within the Patient Safety organization. Responsibilities also include managing deviations, supporting audits, and ensuring adherence to global regulatory requirements.