Quality Assurance Coordinator | Work From Home

Quality Assurance Coordinator: Clario, a part of Thermo Fisher Scientific, has announced an opportunity for a Quality Assurance Coordinator in Bangalore, India, with India Remote flexibility. The position is offered on a full-time basis and is suitable for professionals interested in Quality Assurance, regulatory compliance, clinical research, GxP environments, audits, and inspection readiness.

The role involves coordinating quality and regulatory activities that support the integrity of clinical research and healthcare technologies. The selected professional will work closely with Quality Assurance and Regulatory Compliance teams as well as cross-functional and global stakeholders.

Quality Assurance Coordinator Job Sumary

About the Quality Assurance Coordinator Role

The Quality Assurance Coordinator will play an important role in supporting audit and regulatory inspection readiness activities. The position requires strong organizational skills because the professional will be responsible for coordinating schedules, documentation, stakeholder communications, data requests, and other activities associated with audits and inspections.

The role also involves reviewing documentation to identify missing information, gaps, or potential risks that could affect audit readiness. The candidate will work with different departments and subject matter experts to ensure that required information and supporting evidence are available when needed.

Because Clario operates in a global environment, the position may involve collaboration with teams located in different countries and time zones. Therefore, communication, flexibility, attention to detail, and the ability to manage multiple priorities are important for this role.

Key Responsibilities

The Quality Assurance Coordinator will support a broad range of quality and regulatory compliance activities.

1. Audit and Inspection Coordination: The professional will coordinate activities before, during, and after audits and regulatory inspections. This may include preparing schedules, coordinating meetings, organizing documents, communicating with stakeholders, and tracking required activities.

2. Audit Readiness: A major part of the position is helping teams remain prepared for audits and inspections.The coordinator will work with management and cross-functional stakeholders to ensure that required documentation, evidence, schedules, and other information are available and properly organized.

3. Documentation Management: Quality and regulatory activities require accurate and well-organized documentation. The Quality Assurance Coordinator will help collect, organize, track, and maintain important documents.

Responsibilities may include:

• Organizing supporting evidence
• Maintaining audit documentation
• Tracking data requests
• Maintaining inspection records
• Organizing responses to findings
• Maintaining audit and inspection archives
• Ensuring documentation is stored in appropriate repositories

Attention to detail will therefore be particularly important.

4. Coordination With Stakeholders: The position requires regular interaction with different stakeholders, including Quality Assurance teams, Regulatory Compliance professionals, management, audit hosts, subject matter experts, and other cross-functional teams.

The coordinator will help ensure that stakeholders are aware of schedules, documentation requirements, deadlines, and other activities associated with audits and inspections.

5. Audit Findings and Inspection Observations: The successful candidate will assist with obtaining and tracking responses to preliminary audit findings and inspection observations.

This requires careful documentation and follow-up to ensure that responses and supporting information are properly organized and available to the relevant teams.

6. Quality Systems Support: The role will also provide support for maintaining audit and inspection libraries and related quality-system documentation.

The candidate may participate in activities designed to improve existing processes and documentation practices.

7. Process Improvement: In addition to routine coordination activities, the Quality Assurance Coordinator may participate in special projects and continuous improvement initiatives.

This can involve helping teams improve documentation processes, coordination activities, quality workflows, or audit-readiness practices.

8. Global Collaboration: Clario’s global operations mean that some audits and inspections may require collaboration across different time zones.

The candidate should therefore be flexible and prepared to occasionally work outside standard working hours when required for global quality and compliance activities.

Educational Qualifications

Candidates should have an Associate’s degree, Bachelor’s degree, or an equivalent combination of education, certifications, and relevant experience.

The specific educational background may vary depending on the candidate’s experience and professional qualifications.

Relevant academic backgrounds can include areas such as:

• Pharmacy
• Pharmaceutical Sciences
• Life Sciences
• Biotechnology
• Clinical Research
• Healthcare
• Quality Management
• Regulatory Affairs
• Medical Devices
• Other relevant scientific or regulated-industry disciplines

Experience Required

The position requires a minimum of one year of experience in a GxP-regulated environment or another highly regulated industry.

Experience related to the following areas can be particularly relevant:

• Quality Assurance
• Regulatory Compliance
• Clinical Research
• GxP
• Quality Systems
• Audit Coordination
• Regulatory Inspections
• Documentation Management
• Compliance Programs
• Project Coordination

Experience with audits, regulatory inspections, quality systems, or compliance programs is preferred.

Knowledge of Regulatory and Quality Standards

The job description indicates that working knowledge of regulatory and quality standards is preferred.

Relevant frameworks include:

ICH GCP: International Council for Harmonisation Good Clinical Practice (ICH GCP) provides an internationally recognized framework for the conduct of clinical trials and helps promote the protection of trial participants and the reliability of clinical trial data.

21 CFR Part 11: 21 CFR Part 11 relates to requirements for electronic records and electronic signatures in FDA-regulated environments. Understanding these requirements can be useful for professionals working with electronic quality and clinical documentation.

21 CFR 820: 21 CFR Part 820 has historically addressed FDA Quality System Regulation requirements for medical devices. Candidates working in medical-device environments may benefit from familiarity with applicable current FDA quality-system requirements.

ISO 9001: ISO 9001 is an internationally recognized standard associated with quality management systems and continuous improvement.

ISO 13485: ISO 13485 focuses on quality management systems for organizations involved in medical devices and related regulatory requirements.

ISO 27001: ISO 27001 is associated with information security management systems and provides a framework for managing information-security risks.

Knowledge of one or more of these standards can be valuable depending on the specific responsibilities assigned to the position.

Technical Skills

The Quality Assurance Coordinator should be comfortable using common workplace and documentation tools.

The job description specifically mentions proficiency with:

• Microsoft Outlook
• Microsoft Word
• Microsoft Excel
• Microsoft PowerPoint
• Microsoft Teams

Strong Excel and documentation skills can be particularly useful for maintaining trackers, schedules, audit documentation, action items, and project-related information.

Important Soft Skills

In addition to technical knowledge, the position requires strong professional and interpersonal skills.

Organization: The candidate may need to manage multiple audits, documents, schedules, deadlines, and stakeholders. Strong organizational skills are therefore essential.

Attention to Detail: Quality and regulatory activities depend heavily on accurate documentation. Small errors or missing information can affect audit readiness, making attention to detail important.

Communication: The position requires regular communication with internal teams and stakeholders. Candidates should have strong written and verbal English communication skills.

Time Management: The ability to prioritize multiple activities and meet deadlines is important, particularly during audit and inspection preparation.

Analytical Thinking: The candidate should be able to review documents, identify gaps, recognize potential issues, and communicate relevant information to the appropriate stakeholders.

Teamwork: Although the position requires independent work, the coordinator will regularly collaborate with global and cross-functional teams.

Who Can Apply?

This opportunity may be relevant to professionals with experience in:

Quality Assurance | Regulatory Affairs | Clinical Research | Pharmacovigilance | GxP Compliance | Pharmaceutical Industry | Medical Devices | Healthcare Technology | Quality Systems | Audit Management | Regulatory Compliance

Candidates who have worked in regulated environments and have experience managing documentation, coordinating activities, or supporting compliance programs may find the role relevant to their professional background.

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What Clario Offers

According to the provided job information, Clario offers a range of employee benefits and workplace opportunities.

These include:

Competitive Pay and Incentives: The company offers competitive compensation and incentive opportunities as part of its employee package.

Provident Fund and Medical Insurance: Employees can receive benefits including provident fund and medical insurance.

Employee Programs: Clario provides employee engagement programs and local events intended to support workplace engagement and employee experience.

Modern Work Environment: The position offers access to modern office spaces and remote-work flexibility.

Professional Development: The company provides opportunities for professional development and career growth within a global organization.

Clario and Thermo Fisher Scientific

Clario is part of Thermo Fisher Scientific and operates in the clinical research and healthcare technology space.

The company’s stated purpose is to transform lives by unlocking better evidence. Its work brings together clinical science, technology, and global teams supporting the development of healthcare solutions.

For professionals interested in the intersection of clinical research, healthcare technology, quality, and regulatory compliance, working within such an environment can provide exposure to global quality processes and cross-functional collaboration.

Final Takeaway

The Quality Assurance Coordinator position at Clario is focused on supporting audits, regulatory inspections, documentation, quality systems, and compliance activities. The role combines quality assurance knowledge with strong coordination, communication, documentation, and organizational skills.

Professionals with at least one year of experience in a GxP or highly regulated environment, along with an appropriate educational background and knowledge of quality or regulatory standards, may consider this opportunity.

The position also offers exposure to global quality activities, cross-functional collaboration, audit readiness, and continuous improvement, which are relevant areas for professionals building careers in the pharmaceutical, clinical research, medical-device, and healthcare technology sectors.

Interested candidates should check the latest official job posting for current availability, application instructions, and any updated eligibility requirements before applying.

Disclaimer: The information in this article is based on the job description provided. Job requirements, availability, location options, and other details may change. Candidates should verify the latest information through the employer’s official careers portal.

Editorial Note

This article has been carefully researched and written by Deepak Rajput with a focus on accuracy, clarity, and evidence-based healthcare information. Pharmaacademias.com