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Osd Production Qms Officer

2-4 years
Not Disclosed
10 Feb. 17, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

OSD Production QMS Officer at Zydus
Location: Gangtok, Sikkim
Division: Sikkim Formulation II
Job Posted: Jan. 28, 2025
Employee Type: P-P7-Probationer-HO Staff
Experience Range: 2 to 4 years

Job Title: Officer – Production QMS

Qualifications:

  • B. Pharma / M. Pharma
    Experience Required: 2 to 4 years

Key Responsibilities:

  • Documentation:

    • Preparation of SOPs, BMRs, Protocols, Interim and Summary Reports for products.

    • Handling Qualification/Requalification documents.

  • Quality Management:

    • Manage change control, deviations, investigations, and risk assessments.

  • Training:

    • Conduct training sessions for subordinates to eliminate errors and ensure consistent results.

    • Develop and implement monthly training plans.

    • Maintain and update personnel training files.

  • Audits & Compliance:

    • Address observations related to CAC, DR, and Self-Inspection audits.

  • Software Skills:

    • Proficiency in TrackWise, SAP, and other computer applications is essential.

Candidate Requirements:

  • Practical exposure in TrackWise and SAP is highly desirable.

  • Strong computer knowledge and familiarity with QMS processes.

This role is a great opportunity for someone with experience in Quality Management Systems (QMS) and a passion for process improvement within the pharmaceutical industry.