Industry : Pharmaceuticals

Skills : QA, Quality Assurance, QMS, GMP

Job Type : Permanent

Description : An exciting opportunity to manage Quality Assurance and Control for a leading medical devices MNC setting up their base in India.

Client Details :

Our client is a Swiss MNC in the Pharmaceutical space. They are over 60 years old and employ over 3500 people. They operate in a niche and fast growing segment within the Medical Devices space and their products are available in over 70 countries. They have recently decided to invest in India and are looking for a team to lead these efforts.

Job Description :

- The Quality Assurance (QA) manager is an experienced person within the medical device industry with extensive knowledge performing their function within healthcare sector.

- The incumbent has the ability to take strategic direction and establish efficient and compliant processes throughout the organization and has strong communication at all levels.

- This position is to manage the quality assurance group to include incoming inspection, quality assurance, quality compliance, and quality engineering.

- The position is based in India, Mumbai and reports to Head of Operations with a strong functional reporting line to quality assurance team in Basel

- Develop, administer and maintain quality assurance procedures and activities required to ensure that the company's processes and products are in compliance to the medical device quality standards and requirements

- Employ quality assurance methodologies in support of engineering, manufacturing and regulatory functions

- Develop and implement quality control and inspection procedures for receipt and control of incoming materials, in-process materials and final product acceptance activities

- Define quality control standards and test; specify test equipment and procedures.

- Coordinate and steer monthly product quality meetings.

- Establish and maintain test instrument calibration procedures and maintenance schedules.

- Establish quality assurance, quality control inspection and testing procedures.

- Identify quality assurance metrics; analyze and report trends to management.

- Review and responsible to withdraw non-conforming products and stop or released deliveries/shipments

- Active participant in all stages of design development, testing and design control activities, ensuring quality assurance considerations and requirements met.

- Responsible for developing and maintaining sterilization validation and material biocompatibility activities.

- Should exhibit the ability to evaluate requirements for testability, design efficient test cases, and write extensive technical documentation.

- Participate in the review of product requirements, design requirements, software requirements specifications, and functional specifications

- Assist in Risk Management activities and ensure compliance to standards and regulations

- Assist in the failure investigation, product complaints and lead corrective and preventive actions

- Lead preparation for the conduct of regulatory agency inspections

- Coordinate and organize supplier audits, certification audits, customer audits or other inspections. Execute and follow-up on internal audit recommendation.

- Manage and steer the Quality Control team to ensure full compliance towards the Quality Management System, processes and procedures and alignment

Profile :

- The ideal candidate is a change agent who is willing to play an active role in a change environment and supports the ongoing implementation and further transformation of a privately owned business into a subsidiary of a MNC.

- Preferably the candidate has worked in a company with a similar business model (medical manufacturing industry with direct sales model and consignee sales ).

- The position is based in India, Mumbai and reports to Head of Operations with a strong functional reporting line to quality assurance team in Basel.

Job Offer :

- An opportunity to lead the QA, QA and RA for an MNC

- The chance to grow with a new entrant in the medical devices space

Page Group India is acting as an Employment Agency in relation to this vacancy.

Contact : Nupur Mehta

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