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Officer / Sr. Officer – QA Validations | FDC Ltd | Panjim

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People are our greatest strength, and it is our employees who make our company great. We are proud of our talented and committed employees and partners, who have consistently ensured that FDC continues to deliver world-class quality products and services.

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We have a long-standing heritage of commitment to excellence and innovation. These are attributes that have served us well through more than 75 years of growth, and they will continue to serve us in the future.

The combination of creativity, trust, synergy, and transparent corporate governance, coupled with FDC’s outstanding people, holds the promise of a bright future for you.

We have an employee strength of more than 4300, generating a turnover of over Rs 9 billion.

FDC Ltd is one of the leading top Pharma companies in India. Based at Mumbai with leads eight divisions with mix and specialty product Therapy.

FDC Ltd having product therapy Like Antibiotics, Hematological, ENT & related, Respiratory & Anti-Allergic, Nutraceuticals, Analgesics & Anti-inflammatory, and Cardiac /Diabetic.

Position: Officer / Sr. Officer – QA Validations

Location: Panjim, Goa, India

Job Description:

  • To prepare New & Review of existing sops & QAP’s.
  • To ensure all instruments are calibrated and validations are carried out in a timely manner.
  • To review complete batch records (BMR and BPR) prior to release.
  • To perform Qualification of equipment, Utilities & instruments.
  • To conduct Self Inspection.
  • To perform Re-Qualification of equipment as per schedule and preparation & compilation of Protocols.
  • Updation of Validation Master Plan & Site Master File.

  • To review the Planned Preventive maintenance Planner & Calibration Planner.
  • To review Water System & EMS System reports.
  • Audit compliance.
  • Risk Assessment.
  • In absence of QA Head, authorized to sign all the Quality related documents.
  • Any other assignments allocated by Unit Q.A. Head.
  • In absence of QA Head, the following Job Responsibilities shall be shouldered:
  • Implementation of Quality Management System.
  • Review and Approval of Quality Manual, Validation Master Plan (VMP), Site Master File (SMF).
  • Review and Execution of schedules for Preventive Maintenance, Calibration, Equipment, and Process Validation as per Validation Master Plan.
  • To Prepare, Review, and approval of Standard Operating Procedures, Quality Assurance Procedures, methods, specifications in compliance with the GMP requirements.
  • Approval of Master Documents like Batch Manufacturing Record, Batch Packing Record.
  • To ensure that testing is carried out of all the starting materials, Packaging Materials Intermediates, Bulk Products, and Finished Products as per the specifications.

  • Review and approval of Validation / Stability protocols and reports.
  • Handling of Deviations.
  • Handling / Investigation of Product Complaints, Incident Reports, Batch failures, and Product Recalls.
  • Evaluation and approval of Change Controls and Corrective And Preventive Actions (CAPA).
  • Co-coordinating with Regulatory Affairs.
  • Conducting GMP Training. Carrying out of Self Inspection of the facility as per the schedule.
  • Carrying out Equipment qualification, Process Validation, cleaning validation & Product Quality Review.
  • To co-ordinate with the auditors of various external agencies.
  • Vendor assessment and control.
  • Batch Document Review.
  • Regulatory audit handling, review, and compliance.
  • Vendor Assessment.

  • Monitoring of manufacturing environment.
  • To review stability data & shelf life of Products.
  • Responsible for HVAC Validation.
  • Responsible for Compressed Air validation.
  • Responsible for Temperature Mapping (Area & Instruments)
  • Overall administration of the Q.A. department.
  • Any other assignments allocated by Unit QA.

Qualification: B.Pharma

Experience: 3-6 Years

Salary: Negotiable

Contact Details:

pravin.waghole@fdcindia.com

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