Senior Executive Quality Assurance

3 weeks ago

Vadodara, India Maven Profcon Services LLP Full time

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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