Quality Specialist, Quality Process Position at Ergomed in Pune
Ergomed Pune jobs offer a rare chance for professionals in the pharmaceutical quality sector, as the company seeks a Quality Specialist, Quality Process for its Quality Operations team in Pune, Maharashtra. This full-time role offers the flexibility of remote work and is ideal for candidates with experience in Quality Management Systems, GxP compliance, and LMS administration.
About Ergomed
Ergomed is a specialist clinical research organization focused on rare diseases and select oncology indications. The organization supports complex clinical trials and collaborates with biotechnology companies to advance promising therapies through clinical development. Ergomed operates internationally across North America, South America, Europe, Asia, and Australia, providing specialized expertise in clinical research and healthcare development.
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
Ergomed Pune Jobs: Job Description
In this Ergomed Pune jobs opportunity, the Quality Specialist will support Quality Operations at Ergomed, ensuring that controlled procedures, GxP training, and systems access activities are managed in accordance with applicable regulations and company requirements. The role involves collaboration with various teams to maintain compliance and improve quality processes.
Key Responsibilities
- Support Ergomed colleagues and functional teams in developing, managing, and implementing controlled procedures.
- Ensure GxP activities comply with applicable legislation, guidelines, and standards.
- Act as a Subject Matter Expert (SME) for GxP Quality Operations and Training regulations when required.
- Assist in driving GxP training activities across the Ergomed Group.
- Support the management and triage of processes controlling access to the Quality Management System.
- Assist functional and Quality teams during audits and inspections.
- Prepare periodic reports for management regarding Quality Operations and Training metrics.
- Contribute to team development by mentoring Quality Process and Training team members.
Eligibility Criteria
Candidates interested in the Ergomed Quality Specialist position should possess a university degree in Biomedical Sciences, Natural Sciences, Health Sciences, Nursing, Pharmacy, or a related scientific discipline. Relevant professional experience may also be considered.
Required Skills
- LMS Administration
- Quality Management Systems (QMS)
- GxP Compliance
- GCP and GMP awareness
- Controlled Document Management
- GxP Training
- Audit Support
- Inspection Readiness
How to Apply
Interested candidates can apply for the position by visiting the following link: CLICK HERE FOR THE ORIGINAL NOTIFICATION / APPLY ONLINE.
Conclusion
This position at Ergomed presents an excellent opportunity for qualified candidates to advance their careers in pharmaceutical quality and clinical research. For eligible professionals, Ergomed Pune jobs such as this can offer a route into a global Quality Operations team. Interested individuals are encouraged to apply before the deadline.
