Nipro Medical India
Location
Haridwar | India
Job description
Company Description
Nipro Medical India is a subsidiary of Nipro Corporation, Japan, which specializes in medical, pharmaceutical, and glass products. Established in 2010, Nipro Medical India meets the needs of medical professionals and patients through the business sectors of Medical Surgical, Hemodialysis, and Cardio products. We are committed to developing innovative, high-quality solutions to improve patient care and quality of life.
Role Description
This is a full-time on-site role for a QC Manager, located in Haridwar. The QC Manager will be responsible for managing the quality control department, ensuring compliance with all quality systems and regulations, and conducting audits. They will also be responsible for training staff, investigating incidents, and implementing corrective actions.
To lead and drive execution of quality strategy by overseeing elements of quality operations for our two medical device manufacturing plants in Palwal, Haryana and Haridwar, Uttarakhand.
Qualifications
Postgraduate in Science (M. Sc.), Bachelor or Master of Pharmacy (B Pharm/ M Pharm). Must have at least 10 years Quality / Regulatory management experience in a high-volume Medical Device / Pharmaceutical factory environment.
Preferred knowledge, Skills, and abilities:
• Superior organizational and leadership skills with ability to help team grow and thrive.
• Able to lead and front multiple external audits.
• Have in-depth / working knowledge of: ISO 13485, US FDA 21 CFR Part 820
• Have strong self-motivation, the ability to work independently, and within a team environment with strong follow up, organization and prioritization skills and excellent attention. Must have a proven track record of developing and maintaining positive customer relationships.
• Able to lead and manage the performance of a multi-functional team.
• Able to organize and prioritize tasks, must be detail orientated and self-motivated.
• Have excellent written and verbal communication skills. Must be able to work in a fast-paced environment.
• Able to always comply with the company's safety and quality policy.
•Read and interpret data, information, and documents.
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Ability to make independent and sound judgments.
Monthly Travel to Faridabad
Roles and responsibilities:
• Lead the Quality control function for Medical Device manufacturing at Haryana and Uttarakhand.
• The role will have reporting relationship to the NMI group QA Manager to ensure development and alignment of the site business plan including support to the other senior managers.
• Establishing the sites' quality strategy in conjunction with the other members of the Site Leadership Team.
• Cultivate a positive working relationship with Nipro Medical India HO via supporting validation in design and development, product & test specifications, execution of manufacturing in line with agreed standards.
• Develop and champion a quality & patient first organizational culture that promotes behaviors that lead to superior quality, business performance and enterprise excellence.
• Establish, monitor, and report on appropriate Key performance indicators which underpin the performance of Shinrai-Nipro relative to Quality for Operations, Quality System, Product Development and New Product Introductions.
• Responsible for ensuring QA/QC resources have the adequate training, education, competency, and experience to perform their GMP related job functions effectively. Ensure sufficient support in place to support programs and flawless transition into Operations.
• Coach, mentor and lead highly dynamic team members to help achieve the requirements of this position as well as the individual career goals of team members.
• Responsible and accountable for quality departmental budget.
• Accountable for the final disposition of product and for the decision on final batch release of medical device components, sub-assemblies and finished medical devices.
• Ensures all Quality and Regulatory correspondence (internal and external) is aligned and compliant with Shinrai-Nipro policies and guidance.
• Act in accordance with the company's Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all local site company policies, procedures, and corporate policies.
• Perform additional duties at the request of the direct supervisor.
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