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Quality Management Systems (Qms) - Sr. Executive

4-7 years
Not Disclosed
10 Dec. 5, 2024
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

Job Title: Senior Executive - Quality Management System (QMS)

Job Summary:
The Senior Executive in Quality Management System (QMS) is responsible for the development, implementation, and maintenance of the Quality Management System at Promea. This position ensures compliance with regulatory and quality standards and works closely with cross-functional teams, including manufacturing, quality control, and regulatory affairs, to drive continuous improvement within the QMS.

Key Responsibilities:

  • Develop, implement, and maintain the Quality Management System (QMS) to ensure compliance with regulatory and quality standards, including cGMP, ISO 13485, and ISO 9001.
  • Develop and maintain Standard Operating Procedures (SOPs), policies, and forms for the QMS.
  • Plan, coordinate, and execute internal audits to assess compliance with QMS policies and procedures.
  • Participate in the identification and resolution of quality issues, ensuring timely release of pharmaceutical products.
  • Conduct risk assessments to identify potential quality issues and implement corrective and preventive actions (CAPAs).
  • Ensure that all QMS-related documents and records are maintained per company policies and regulatory requirements.
  • Participate in regulatory inspections and audits, providing timely responses to observations and findings.
  • Prepare quality metrics and trending reports to drive continuous improvement of the QMS.

Qualifications:

  • Bachelor's degree in Science (B.Sc) or Pharmacy (B.Pharm).
  • Minimum of 5 years of experience in Quality Assurance within the pharmaceutical industry.
  • Strong knowledge of quality systems and regulations, including cGMP.
  • Experience with process validation and statistical analysis.
  • Excellent communication, organizational, and problem-solving skills.
  • Ability to work independently and collaboratively within a team.