Ergomed is hiring a Quality Specialist, Quality Process for its Quality Operations team in Pune, Maharashtra, India. This opportunity is particularly relevant for professionals with experience in Quality Management Systems (QMS), GxP compliance, controlled procedures, GxP training, and LMS administration.
The Ergomed Quality Specialist job in Pune is a full-time position with remote work flexibility. The selected candidate will support controlled procedures, Learning Management System (LMS) administration, GxP training activities, system access management, quality metrics, audits, CAPA, deviations, and business continuity activities.
For professionals looking to build a career in pharmaceutical quality, clinical research quality, GxP compliance, and Quality Management Systems, this Ergomed opportunity offers exposure to global quality operations.
Job Details
- Company: Ergomed
- Job Title: Quality Specialist, Quality Process
- Department: Quality Operations – Quality Process
- Location: Pune, Maharashtra, India
- Work Arrangement: Remote work flexibility
- Employment Type: Full-time
- Key Requirement: LMS Administration Experience
- Qualification: Biomedical, Natural or Health Sciences degree
- Industry: Clinical Research / CRO / Healthcare
About Ergomed
Ergomed is a specialist clinical research organization focused on rare diseases and select oncology indications. The organization supports complex clinical trials and works with biotechnology companies to advance promising therapies through clinical development.
The company operates internationally across North America, South America, Europe, Asia, and Australia, supporting clinical research and healthcare development through specialised expertise and global collaboration.
Quality Specialist Job Responsibilities
As a Quality Specialist, Quality Process at Ergomed, you will support Quality Operations and ensure controlled procedures, GxP training, and systems access activities are managed in accordance with applicable regulations and company requirements.
Leadership and GxP Compliance
Key responsibilities include:
- Support Ergomed colleagues and functional teams in developing, managing, and implementing controlled procedures.
- Ensure GxP activities comply with applicable legislation, guidelines, and standards.
- Support compliance with relevant standards, including ICH, CIOMS, and ISO requirements.
- Act as a Subject Matter Expert (SME) for GxP Quality Operations and Training regulations when required.
- Provide input into quality procedures, policies, and training activities.
- Support the Ergomed Quality Management System and quality processes.
GxP Training and LMS Administration
The Quality Specialist will support GxP training activities across the organisation.
Responsibilities include:
- Assist in driving GxP training activities across the Ergomed Group.
- Help ensure employees receive appropriate training to meet global GxP requirements.
- Track training activities through completion.
- Support efficient and effective training processes.
- Work closely with the Learning and Development team.
- Support excellence in training and compliance activities.
- Contribute to LMS administration and training management activities.
Quality Management System (QMS) Activities
The selected candidate will also support the Quality Management System (QMS).
Responsibilities include:
- Assist with the management and triage of processes controlling access to the Quality Management System.
- Participate in projects focused on improving QMS efficiency.
- Support the management and use of controlled systems.
- Review and approve system access requests for employees and clients.
- Support controlled document and quality process activities.
Audit and Business Continuity Support
Additional responsibilities include:
- Support Business Continuity activities across the Ergomed Group.
- Assist functional and Quality teams during audits and inspections.
- Provide required reports and procedures from the Quality Management System.
- Support audit readiness and inspection activities.
Quality Metrics, CAPA and Deviation Management
The role also involves quality reporting and continuous improvement activities.
Responsibilities include:
- Assist with preparing Quality Operations and Training metrics.
- Analyse quality and training-related data.
- Prepare periodic reports for management.
- Support the preparation of CAPA records.
- Support Deviation records resulting from controlled document, GxP training, and Business Continuity Process issues.
Team Development
The Quality Specialist may also contribute to team development by:
- Assisting in mentoring Quality Process and Training team members.
- Supporting the development of competence and subject matter expertise.
- Promoting a collaborative and high-performing quality culture.
- Supporting global teams across different regions.
- Providing coaching and professional development support.
- Contributing to succession planning and team capability development.
Qualifications and Eligibility
Candidates interested in the Ergomed Quality Specialist jobs in Pune should have an educational background in Biomedical, Natural, Health, or related Scientific Sciences.
Required Qualification
A university degree in one of the following areas is required or preferred:
Biomedical Sciences, Natural Sciences, Health Sciences, Nursing, Pharmacy, B.Pharm, M.Pharm, B.Sc, M.Sc, Biotechnology, Microbiology, Biochemistry, Life Sciences, or another relevant scientific discipline.
Candidates with suitable relevant professional experience may also be considered.
Skills That Can Be Relevant for This Role
The job description highlights several important areas of knowledge. Relevant skills may include:
- LMS Administration
- Learning Management Systems
- Quality Management Systems (QMS)
- GxP Compliance
- GCP and GMP awareness
- Controlled Document Management
- SOP Management
- GxP Training
- Quality Operations
- CAPA Management
- Deviation Management
- Audit Support
- Inspection Readiness
- ICH Guidelines
- CIOMS Guidelines
- ISO Standards
- Business Continuity Planning
- Quality Metrics and Reporting
- System Access Management
- Communication and Collaboration
Is This Job Suitable for B.Pharm and M.Pharm Graduates?
Yes. Pharmacy graduates may be suitable for this position because Ergomed specifically accepts candidates with a degree in Pharmacy or another relevant scientific discipline.
Therefore, candidates with B.Pharm, M.Pharm, Pharm.D, and relevant Quality, Clinical Research, Pharmacovigilance, Regulatory Affairs, or GxP experience may find this opportunity relevant.
However, LMS administration experience is specifically mentioned in the job title, making relevant practical experience particularly valuable.
Is This Job Suitable for Freshers?
The job description does not specify a minimum number of years of experience.
However, this is a Quality Specialist role with LMS administration responsibilities, along with involvement in GxP training, QMS processes, audits, CAPA, deviations, and controlled procedures.
Therefore, candidates with relevant experience in Quality Assurance, GxP, QMS, LMS administration, Clinical Research Quality, or pharmaceutical quality systems may be more competitive.
Freshers should carefully review the official application requirements before applying.
Estimated Salary for Ergomed Quality Specialist in Pune
Ergomed has not disclosed the official salary in the provided job posting.
Based on the responsibilities and the Indian pharmaceutical and clinical research market, an estimated salary range for a Quality Specialist in Pune may be:
₹5 LPA to ₹11 LPA per year
The actual salary may vary based on:
- Relevant experience
- LMS administration expertise
- GxP and QMS knowledge
- Educational qualifications
- Previous Quality Assurance experience
- Internal compensation structure
Note: This is an editorial salary estimate and is not an official salary disclosed by Ergomed.
Benefits of Working at Ergomed
Ergomed highlights a collaborative and international work environment focused on meaningful clinical research.
Potential career advantages include:
- Exposure to global clinical research operations
- Experience in rare disease and oncology research
- International collaboration
- Opportunities to work with Quality Management Systems
- GxP training and compliance exposure
- Professional development opportunities
- Collaborative work culture
- Career growth opportunities
- Flexible working arrangements where applicable
- Work-life balance initiatives
Specific employee benefits may vary depending on location, employment terms, and company policy.
Why Consider a Career in Quality Process and LMS Administration?
Quality Process professionals play an important role in ensuring that pharmaceutical and clinical research organisations operate according to established procedures and global regulatory requirements.
Experience in Quality Management Systems, GxP compliance, LMS administration, controlled documents, CAPA, deviations, and audit support can create career opportunities across:
- Clinical Research Organisations (CROs)
- Pharmaceutical Companies
- Biotechnology Companies
- Quality Assurance Departments
- Clinical Quality Teams
- GxP Compliance
- Quality Management Systems
- Learning and Development
- Regulatory Compliance
- Document Control
Professionals with expertise in LMS administration and GxP training are particularly valuable in organisations that manage global training and compliance requirements.
How to Apply
