Quality Assurance Specialist

Job Description

About Company:

Alkem MedTech Pvt Ltd is a wholly owned subsidiary of Alkem Laboratories Ltd, which is the 5th largest listed Pharmaceutical company in terms of market share. As the first MedTech venture of Alkem Labs, Alkem MedTech is dedicated to advancing precision, high-risk, and implantable medical devices along with their accessories. MedTech is a strategic priority for Alkem Labs, representing a significant growth avenue. We are beginning our MedTech journey by focusing on Musculoskeletal solutions and have plans to expand into multiple segments, establishing a robust, multi-faceted MedTech company in the near future.

Alkem MedTech will be manufacturing in India, aligning with the vision of the Government of India to boost domestic production and innovation in the medical technology sector.

We are looking for passionate and innovative talents to join our pioneering team. If you are excited about shaping the future of medical technology and want to be part of a transformative journey, Alkem MedTech is the place for you.

Why Join Us

Innovation-Driven Environment: Work on cutting-edge technologies in precision and implantable

medical devices.

Growth Opportunities: Be part of a strategic growth initiative for one of the leading pharmaceutical

companies and be part of creating a legacy.

Collaborative Culture: Engage with a team of dedicated professionals committed to making a difference

in healthcare.

Impactful Work: Contribute to life-changing medical solutions in the Musculoskeletal segment and beyond.

Manufacturing in India: Support the vision of the Government of India by contributing to domestic

production and innovation in the MedTech sector.

Join us at Alkem MedTech and help shape the future of healthcare technology.

Purpose of the role:

The QA/QC Specialist will play a critical role in ensuring product quality and regulatory compliance in the manufacturing of medical devices. This position is responsible for overseeing quality assurance and control processes, particularly in manufacturing, to ensure that all products meet stringent quality standards and regulatory requirements. The role includes monitoring manufacturing operations, conducting inspections, managing quality systems, auditing, and participating in continuous improvement initiatives.

Roles & Responsibilities:

1. Quality Oversight

- Supervise and implement quality control measures across manufacturing operations to

ensure compliance with ISO 13485, FDA QSR, and other applicable regulatory standards.

- Conduct regular in-process and final inspections of products to identify defects and

ensure they meet specifications.

2. Manufacturing Process Monitoring

- Collaborate with manufacturing teams to monitor and control production processes,

ensuring adherence to Good Manufacturing Practices (GMP).

- Review and approve manufacturing process documentation, including SOPs, work

instructions, and validation protocols.

3. Quality Systems Management

- Maintain and support the quality management system (QMS), including corrective action

and preventive action (CAPA), non-conformance, and complaint handling.

- Conduct root cause analyses and drive effective CAPAs for product and process non-

conformances.

4. Risk Management

- Participate in risk management activities, such as Failure Mode and Effects Analysis

(FMEA), to assess and mitigate risks related to manufacturing processes.

- Support the creation of risk management files in compliance with ISO 14971 standards.

5. Documentation and Reporting

- Prepare, review, and maintain quality documentation, including batch records, inspection

records, and test reports.

- Ensure accurate and timely reporting of quality metrics, and present findings to

management.

6. Internal and External Audits

- Participate in internal audits to ensure compliance with regulatory and quality standards.
- Support external audits by regulatory agencies, notified bodies, and customers as

needed.

7. Continuous Improvement

- Identify opportunities for improvement within the manufacturing process and participate

in continuous improvement initiatives.

- Collaborate with cross-functional teams, including engineering, R&D, and production, to

enhance product quality and operational efficiency.

8. Training

- Provide training and guidance to production staff on quality control and manufacturing

best practices.

- Ensure all team members adhere to quality and regulatory standards during

manufacturing operations.