Job Description

About us


MERIL


DELIVERING WORLD-CLASS HEALTHCARE SOLUTIONS







Founded in 2006, Meril is an India-based, global medical device company that is dedicated to the innovation, design and development of novel, clinically relevant and state-of-the-art devices. Our fundamental aim is to champion the alleviation of human suffering and improve quality of life. To enable this, we are committed to R&D, innovation in manufacturing medical technology, scientific communication, and contemporary distribution avenues.



Meril was born with the aim of improving the quality of human life through innovative and advanced healthcare solutions. As a medical device manufacturer, we exist to improve the inventiveness in healthcare so that people's lives are enriched. We continually seek excellence in providing answers to some of medicine's toughest questions.



Meril manufactures medical solutions in the form of vascular intervention devices, orthopaedic supplements, in-vitro diagnostics, endo-surgery and ENT products. It is our core commitment to ensure the delivery of advance healthcare solutions. Our inclination towards research and development is reflected in our diverse offerings. We ensure that we adhere to the best quality of standards in manufacturing, scientific communication and distribution to deliver path-breaking healthcare products to the world.



We collaborate with physicians and global innovators to identify unmet clinical needs and develop revolutionary therapies. We encourage research and academic collaborations and remain available to interact on exciting opportunities.



Headquartered in India with a manpower of more than 4000, Meril currently conducts business in more than 100 countries. We have 100% subsidiaries in India, USA, Germany, Brazil, Russia, South Africa, Bangladesh and Turkey. We have set up operations in China and Japan too.






1. Responsible for QA activities like change control, deviation, OOS, product non-compliance, CAPA, and product complaints.



2. Assuring GMP compliance through out the plant as per ISO and regulatory requirements.



3. Responsible for document and data control of entire plant.



4. Ensuring compliance for the deficiencies raised during GMP round.



5. To involve in root cause analysis and initiate CAPA for the non-conformance raised during regulatory audit.



6. Review and updation of department SOP's as and when required.



7. Reviewing of VMP, validation protocols and reports like process validation, sterilization validation, clean room validation and others.



8. To identify and monitor department objectives for the completion.



9. Interaction and co-ordination with other departments during validation activities to meet regulatory compliance.



10. To review that the annual training is delivered to plant employees as per the schedule.



11. Planing of Internal Quality audit and compiling the non-conformance report with supporting evidence.



12. Interact and conduct meetings with other departments for Change control, CDCR, deviations, non-conformance and other day-today activities.


13. Provide assurance that the product is analyzed and released as per the laid down specifications.

Requirements


1. M.Pharm with specialization in QA from reputed college/ university with good academic record.



2. Knowledge on cGMP and other regulatory guidelines.



3. Reviewing skill for accuracy of documents and completeness of data.



4. Awareness of QMS system and validations activities.



5. Should have good communication and problem solving skills.



6. Should be reliable and focused having an in-depth thought process.


7. Should be able to guide and manage a team of around 8-10 employees.


8. Should have experience in the field of Medical Device File

Benefits


Requirement for MMI2, MMI3 and MMI4 QA department.



Work Experience


5+ years
Industry


Manufacturing
City


Pardi
State/Province


Gujarat
Country


India
Zip/Postal Code


396191