Job Description

About Leading-Biotechnology-CompanyANSR, a market leader in enabling organizations to build, manage and scale global teams, is partnering with a renowned biotechnology company who is redefining the future of human health by providing solutions to some of the most complex problems in the healthcare industry. They are committed to making precision medicine accessible and carries out their business operations in an environmentally sustainable way.Now is your opportunity to join their innovative team in Bengaluru, India. For over 20 years now, companies cutting across size, industry and markets have relied on ANSRxe2x80x99s expertise to successfully build global business and technology teams. We can help you land a rewarding career in this dynamic industry.If you are eager to contribute to a company with strong values, a supportive environment and where you get opportunities to work on challenging projects that uses cutting-edge technology to improve millions of lives, this is your chance to join a truly remarkable team. Apply today!ANSR is hiring for one of our client.Responsibilities:

• Acts as Lead auditor for Supplier and Channel Partner audits in Europe, supporting the global programs.
• Leads regional follow up activities to drive process standardization and continuous improvement for Supplier & Channel Partner programs
• Responsible for leading evaluation and qualification activities of Suppliers.
• Create, manage, and monitor Europe Quality data reports in collaboration with colleagues.
• Perform exploratory data analysis to understand the current state, existing opportunities, and potential future enhancements and solutions, as well as being able to summarize and present results to the leadership
• Works with strategic partners and suppliers to ensure global awareness and compliance to procedures and specifications
• Ability to provide training to other team members to ensure consistency and compliance to processes and procedures where applicable.
• Other such duties that may be determined by Management.

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position.Requirements:

• Experience conducting compliance audits, experience with auditing suppliers preferred.
• Experience with Non-conformance Handling, Failure Investigation (CAPA / SCAR) & Root Cause Analysis.
• Excellent attention to detail, well organized and able to work independently and in teams.
• Experience in Data Analysis techniques.
• Ability to work effectively in a fast-paced, dynamic environment with shifting and competing priorities.
• Experience with electronic product life cycle (PLM) systems such as Agile, SAP or other PLM systems.
• Practical experience in FDA and ISO regulated environments is preferred.
• Ability to travel domestically and internationally as needed.

All listed requirements are deemed as preferred functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.Experience / Education:

• Bachelors Degree or equivalent in a technical discipline with 5+ years of experience.
• Experience working in a regulated environment, in-vitro diagnostics preferred.
• Changes to individual responsibilities may occur due to business needs and other related duties may be assigned.

Scope of Responsibilities:

• Applies core knowledge and understanding of area of specialization to provide solutions in creative and effective ways.
• Assesses unusual circumstances and uses sophisticated analytical and problem-solving techniques to identify cause and suggest variations in approach.
• Works on assignments of diverse scope where information is limited and problem solving requires adaptation of existing techniques.
• Enhances internal and external working relationships and networks with senior partners within area of expertise.
• Adapts style to differing audiences and often advises others on difficult matters that require persuasion.
• Work is done independently and is reviewed at critical points.
• Uses evaluation, judgment, and interpretation to select best course of action.

Experience / Education:

• Typically requires a minimum of 5 years of related experience with a Bachelors degree; or 3 years and a Masters degree; or a PhD without experience; or equivalent work experience.

Leading-Biotechnology-Company