Assistant Manager

1 day ago

Baddi, India Fresenius Kabi Full time

Role: - Assistant Manager -Vendor Management QM.

Location: Baddi

Company: Fresenius Kabi Oncology Ltd.

Key Responsibilities:

  • To establish, execute and monitor compliance with the procedure for the selection, qualification, development, maintenance, and discontinuation of External Providers (Suppliers of materials & services).
  • Collection of Supplier audit needs from FKOL sites and co-ordination with FK Global Sourcing teams to finalize Global Audit Planners.
  • Track and Execute supplier audits assigned to FK-India as per the global planner and maintain up to date status in the global External Audit Management database, with regular updates to FK Global Sourcing team.
  • Management QA activities for supplier qualification requests (new supplier, new material, alternate suppliers, new projects) from PU-Baddi, FKOL Gurgaon and FK-Global (other PUs).
  • Regular communications and tracking of ongoing supplier qualification activities in co-ordination with project management, purchasing and respective production units.
  • Support for implementation of Global initiatives for improvement of Supplier Management process at FK-India (e.g. Quality Agreement Tracking/Update, Global AVL, updated global SOPs etc.).
  • Management of up to date status of Supplier Audits in the FKOL Audit Management System.
  • Support for regular monitoring of suppliers (periodic reviews, re-qualification etc.) for suppliers.
  • To provide the support for regulatory inspections by technical & quality inputs (specifically for Supplier Management process) through regular visits and checks across all FKOL manufacturing sites.
  • To perform the QM inspections for FKOL manufacturing facilities to ensure the compliance with established GMP and GLP standards.
  • To review & support for compliance with data integrity standards at all FKOL manufacturing sites by performing regular inspections focused on data integrity checks, challenging the site procedures for data integrity compliance, random review of batch manufacturing records, analytical records, paper based raw data, electronic data and audit trails.
  • To qualify and monitor the product quality of contract manufacturing sites (third party and P2P products) through the scheduled audits.

Qualifications: M.Sc/B,Pharma or equivalent.

Experience:

10-14 years of hands-on experience in pharmaceutical industry specifically covering QMS and Vendor management activities pertaining to API facilities, CMO, Packing material, Quality Control, Investigations and Validation.

Skills:

o Strong understanding of USFDA, EMA, MHRA, and other regulatory requirements.

o Familiar with ICH, 21CFR Part 210/211/11, EU-GMP, PIC/S GMP and other regulatory requirements.

o Good Knowledge of Quality Management Systems and current quality trends

o Good exposure in QA functions of QMS and production units

Strengths:

o Proven regulatory compliance expertise.

o Effective communication, with strong analytical, interpersonal, and problem-solving skills. Takes initiatives, ownership, and responsibility of assigned activities.

o Goal oriented, Self-driven with strong commitment to work.

o Strong report writing, reading, presentation, and investigational skills

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