Compliance Sme

7 months ago

Bengaluru, India Cytiva Full time

**Be part of something altogether life-changing**

Working at Cytiva in the Life Sciences industry means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40 countries, Cytiva is a place where every day is a learning opportunity - so you can grow your career and expand your skills in the long term.

Cytiva is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.

**IT R&D Compliance SME**

**What you’ll do**
- Regulatory Compliance: Stay current with relevant GXP regulations, including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP), and ensure that IT R&D activities adhere to these standards.
- Documentation and SOPs: Develop, review, and maintain SOPs and documentation related to GXP compliance, ensuring clarity and accuracy in processes and practices.
- Audits and Inspections: Lead and support internal audits to assess compliance with GXP standards.
- Validation and Verification: Oversee the validation and verification of IT systems, software, and processes to ensure they meet GXP requirements and are fit for purpose.
- Quality Management System (QMS): Lead/Support within the IT R&D Team quality control, quality assurance, risk management, and continuous improvement processes.
- Training and Education: Provide training and guidance to IT R&D teams to promote awareness of GXP standards and compliance requirements.
- Risk Management: Identify, assess, and manage quality and compliance risks associated with IT R&D projects, systems, and practices. Develop strategies to mitigate risks.
- Change Control: Manage change control processes to ensure that modifications to IT systems and processes do not compromise quality, safety, or compliance.

**Who you are**
- Educational Background: A bachelor's or advanced degree in a relevant scientific or engineering field, such as chemistry, biology, pharmacy, or a related discipline.
- Industry Experience**: Significant experience (typically 5+ years) in quality assurance and compliance roles within a regulated industry, such as pharmaceuticals, biotechnology, medical devices, or healthcare.
- Regulatory Knowledge**: In-depth understanding of relevant regulatory requirements, standards, and guidelines, including but not limited to GxP.
- Certifications**: Possession of relevant certifications, such as Certified Quality Auditor (CQA), Certified GxP Professional, or other industry-specific certifications, can be an asset.
- Technical Skills**:Proficiency in using quality management tools and software for data analysis, documentation, and quality control processes.
- Communication Skills**:Strong verbal and written communication skills to effectively convey complex regulatory information and compliance issues to both technical and non-technical team members.
- Analytical Thinking**:Ability to critically analyze processes, data, and regulatory requirements to identify compliance gaps and recommend effective solutions.
- Leadership and Collaboration**:Leadership qualities to guide and influence team members and cross-functional teams toward compliance goals. Collaboration skills are essential for working with various departments.
- Attention to Detail**: Meticulous attention to detail to ensure that documentation, processes, and systems adhere to strict quality and regulatory standards.
- Problem-Solving Abilities**: Strong problem-solving skills to address compliance deviations, non-conformances, and CAPAs effectively and efficiently.

LI-VK1

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful **Danaher Business System** tools and the stability of a tested organization.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

If you’ve ever wondered what’s within you, there’s no better time to find out.

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