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Quality Management Systems (Qms) - Sr. Executive

4-7 years
Not Disclosed
10 Feb. 10, 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

Position: Sr. Executive - Quality Management Systems (QMS)
Experience Required: 4-7 years
Location: Hyderabad
Employment Type: Full-Time

Job Summary:

The Sr. Executive in QMS is responsible for the development, implementation, and maintenance of the Quality Management System (QMS) at Promea to ensure compliance with regulatory and quality standards. This role involves collaboration with cross-functional teams, including manufacturing, quality control, and regulatory affairs, to continuously improve the QMS.


Key Responsibilities:

  1. QMS Development and Maintenance:

    • Develop, implement, and maintain the Quality Management System to ensure compliance with regulatory and quality standards, such as cGMP, ISO 13485, and ISO 9001.
  2. SOP and Documentation Management:

    • Develop and maintain Standard Operating Procedures (SOPs), policies, and forms related to the Quality Management System.
  3. Internal Audits:

    • Plan, coordinate, and execute internal audits to ensure adherence to QMS policies and procedures.
  4. Quality Issue Resolution:

    • Collaborate in identifying and resolving quality issues to ensure timely release of pharmaceutical products.
  5. Risk Assessments and CAPA:

    • Conduct risk assessments to identify potential quality issues and implement corrective and preventive actions (CAPA).
  6. Document and Record Maintenance:

    • Ensure that all documents and records related to the QMS are maintained in compliance with company policies and regulatory requirements.
  7. Regulatory Inspections and Audits:

    • Participate in regulatory inspections and audits, ensuring timely responses to observations and findings.
  8. Quality Metrics and Reporting:

    • Prepare quality metrics and trending reports to drive continuous improvement in the Quality Management System.

Qualifications:

  • Educational Requirements:

    • Bachelor’s degree in Science (BSc) or Pharmacy (B.Pharm).
  • Experience:

    • Minimum of 5 years of experience in Quality Assurance within the pharmaceutical industry.
  • Skills and Knowledge:

    • Strong knowledge of quality systems and regulatory requirements, particularly cGMP.
    • Experience with process validation and statistical analysis.
    • Excellent communication, organizational, and problem-solving skills.
    • Ability to work both independently and as part of a team.