Senior Executive Quality Assurance

7 days ago

Ahmedabad, Gujarat, India Maven Profcon Services LLP Full time ₹ 20,00,000 - ₹ 25,00,000 per year

Key Responsibilities:

  • Lead preparation and implementation of ISO 13485, MDSAP, and 21 CFR Part 820 compliance.
  • Manage the preparation of the Design Dossier along with other documents and ensure compliance with EU MDR requirements.
  • Conduct gap analysis of client QMS and MDD/MDR documentation.
  • Draft, review, and approve stability study protocols, reports, and validation documentation.
  • Organise and oversee Internal Quality Audits (IQA) and Management Review Meetings (MRMs).
  • Plan and execute predefined visits based on client needs and predetermined agendas.
  • Conduct internal audits of systems and processes to identify non-conformances and drive closure.
  • Update technical documentation (CER, PSUR, PMCF) on an annual basis.
  • Monitor quality objectives and provide reports on performance and improvements.
  • Prepare clients for recertification and surveillance audits with necessary documentation and training.
  • Perform data analysis and recommend process improvements for manufacturing and compliance.
  • Conduct training programs to enhance employee awareness and regulatory compliance culture.
  • Verify record-keeping practices across departments for accuracy and effectiveness.
  • Provide expert consultation to clients on Good Manufacturing Practices (GMP) and overcoming manufacturing challenges.
  • Act as the primary liaison with clients, auditors, and regulatory bodies during inspections and audits.

Qualifications & Experience:

  • Bachelor's or Master's degree in Life Sciences, Pharmacy, Biomedical Engineering, or related field.
  • Minimum 2-3 years of experience in Quality Assurance
  • Strong knowledge of ISO 13485, MDSAP, 21 CFR Part 820, EU MDR, and related standards.
  • Proven experience in audit preparation, documentation, closure of non-conformances and CAPA
  • Hands-on experience in drafting technical files, CER, PSUR, and PMCF reports.
  • Excellent communication, leadership, and client management skills.

Key Competencies:

  • Strong analytical and problem-solving skills.
  • Attention to detail with a structured and methodical approach.
  • Ability to manage multiple client projects simultaneously.
  • Leadership qualities with team mentoring and client-handling skills.
  • Commitment to continuous improvement and regulatory excellence.

Job Location: Makarba, Ahmedabad

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