Biotech Healthcare | Executive QMS | ahmedabad
2 weeks ago
Role Objective:
A key objective of this profile is to responsible for supporting the implementation, maintenance, and continual improvement of the Quality Management System (QMS) in line with regulatory requirements and internal standards. Role includes executing quality assurance activities, managing documentation, conducting audits and leading training programs to ensure compliance, quality, and operational excellence across the organization.
Desired CandidateProfile:
- Bachelor’s or Master’s degree in Quality Assurance, Life Sciences, Engineering or a related field.
- 3-5 years of experience in quality management systems, preferably within the medical device, pharmaceutical, or biotech industry.
- Strong understanding of applicable regulations and standards (e.g., ISO 9001, ISO 13485, cGMP).
- Experience in CAPA management, internal audits, non-conformance handling and complaint resolution.
- Excellent communication, organizational and analytical skills.
- Ability to work collaboratively with cross-functional teams and stakeholders.
Role & Responsibilities:
- Maintain and improve the Quality Management System (QMS) to ensure compliance with regulatory requirements and company policies.
- Support the creation, review and updating of company procedures and documentation in alignment with QMS guidelines.
- Execute and monitor QMS activities, including complaint handling, non-conformance management, CAPA, documentation control and management reviews.
- Collaborate with process owners to develop and implement necessary procedures and protocols.
- Conduct internal audits and inspections to evaluate the effectiveness of the QMS and ensure continuous improvement.
- Lead investigations of non-conformances and customer complaints, coordinating corrective and preventive actions to resolve issues.
- Conduct routine GMP audits, mock recalls, traceability exercises and plant inspections.
- Provide ongoing quality assurance support to all departments and ensure supplier quality compliance.
- Develop and deliver training programs on quality-related topics to maintain awareness of QMS requirements.
- Assist in regulatory compliance activities in coordination with Regulatory Affairs.
- Ensure timely follow-up on quality issues and ensure all tasks are completed within established timelines.
Functional Skills Required:
- Strong knowledge of quality management systems and relevant regulatory standards (ISO 9001, ISO 13485, GMP).
- Proficiency in quality assurance tools and methodologies such as CAPA, root cause analysis, and internal auditing.
- Excellent documentation, reporting, and record-keeping skills.
- Ability to manage multiple tasks simultaneously with a high level of attention to detail.
- Proficient in quality management software and other relevant tools.
Behavioral Skills Required:
- Strong analytical and problem-solving abilities with a proactive approach to identifying issues and resolving them.
- Excellent interpersonal and communication skills for effective collaboration with teams and stakeholders.
- High attention to detail and commitment to maintaining quality standards.
- Ability to work independently and in team settings within a fast-paced environment.
- Adaptability and openness to taking on new responsibilities and challenges as needed.
Team Size to be Handle:
- Individually Contributory Roll, reporting to Assistant Manager – QMS.
Learn more at:
Biotech is an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground including gender, race, religion, age, sexual orientation, disability, etc.
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