Assistant Manager

2 days ago

Baddi, Himachal Pradesh, India Fresenius Kabi Full time ₹ 20,00,000 - ₹ 25,00,000 per year

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

  • Assistant Manager

    1 week ago

    Baddi, Himachal Pradesh, India Gopal Lifesciences Full time ₹ 8,00,000 - ₹ 12,00,000 per year

    Assistant Manager in the HR & IR Department of a pharma plant handles Industrial Relations (IR) and Human Resources (HR) operations, ensuring legal compliance, managing employee grievances and conflicts, maintaining labor law adherence,

  • Assistant Manager

    2 days ago

    Baddi, Himachal Pradesh, India Acme Generics Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Manage QMS activities: Change Control, Deviation, CAPA, OOS, OOT, Lab Events.Conduct Risk Assessments, SOP reviews, and assist in grievance handling.Document & review: Specifications, SOPs, Test Data Sheets, Analytical Test Reports, and Master documents.Review Method Validation Protocols & Reports.Monitor calibration and preventive maintenance...

  • Executive Assistant to Managing Director

    2 weeks ago

    Baddi, Himachal Pradesh, India Mediwell Biotech Full time ₹ 1,80,000 - ₹ 5,40,000 per year

    Mediwell, a WHO-GMP certified pharmaceutical company specialising in OSD Formulations. Our Managing Director oversees operations, factory visits, external meetings, and coordination with multiple stakeholders. We are looking for a reliable, organized, and proactive assistant to streamline his schedule and ensure nothing slips through the cracks.The Executive...

  • Assistant Manager

    5 days ago

    Baddi, Himachal Pradesh, India Acme Generics Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Key Responsibilities:Manage all Analytical Quality Assurance (AQA) activities.Review, approve, and close Quality Management System documents related to QC.Act as Single Point of Contact (SPOC) for submission activities Dossier, Regulatory, Variation filings.Handle customer communications related to QA.Review manufacturing, packing, analytical reports of...

  • Assistant Manager

    4 weeks ago

    Baddi, Himachal Pradesh, India Acme Generics Full time

    Following will be the responsibilities of the position holder: 1. To ensure cGMP compliance at site. 2. Responsible for Vendor Qualification and Management 3. Day-to-day coordination with QA-representative w.r.t. Vendor Qualification/Re-Qualification and Management status. 4. To review vendor documents for Vendor Qualification. 5. To perform the Vendor...

  • Assistant Manager

    4 weeks ago

    Baddi, Himachal Pradesh, India Acme Generics Full time

    Following will be the responsibilities of the position holder:1. To ensure cGMP compliance at site.2. Responsible for Vendor Qualification and Management3. Day-to-day coordination with QA-representative w.r.t. Vendor Qualification/Re-Qualification and Management status.4. To review vendor documents for Vendor Qualification.5. To perform the Vendor audit and...

  • Assistant Manager

    3 weeks ago

    Baddi, Himachal Pradesh, India Acme Generics Full time

    Following will be the responsibilities of the position holder: 1. To ensure cGMP compliance at site. 2. Responsible for Vendor Qualification and Management 3. Day-to-day coordination with QA-representative w.r.t. Vendor Qualification/Re-Qualification and Management status.4. To review vendor documents for Vendor Qualification. 5. To perform the Vendor audit...

  • Assistant Manager

    3 days ago

    Baddi, Himachal Pradesh, India Acme Generics Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Following will be the responsibilities of the position holder:To ensure cGMP compliance at site.Responsible for Vendor Qualification and ManagementDay-to-day coordination with QA-representative w.r.t. Vendor Qualification/Re-Qualification and Management status.To review vendor documents for Vendor Qualification.To perform the Vendor audit and its compliance...

  • HR Assistant

    2 weeks ago

    Baddi, Himachal Pradesh, India Royal Enfield Full time ₹ 1,44,000 - ₹ 2,16,000 per year

    Post job ads and vacancies on job boards and social mediaScreen resumes and job applicationsSchedule and coordinate job interviewsAssist in background and reference checksAssist in preparing job offer lettersProvide support during recruitment activities like job fairs and career events.Maintain accurate and up-to-date employee records, including personal...

  • Assistant Manager Npd

    2 days ago

    Baddi, Himachal Pradesh, India Tds Placements Full time ₹ 2,00,000 - ₹ 6,00,000 per year

    Independently manage NPD Packaging projects for Cosmetics packaging2. Knowledge of Injection moulding, EBM, ISBM.3. Coordination with Vendors, Tool Makers for mould development. Required Candidate profileIndependently manage NPD Packaging projects for Cosmetics packaging