Samahitha is seeking a skilled Quality Control (QC) professional to join their team in Bengaluru, Karnataka. This role involves preparing audit plans, conducting audits, and reviewing reports to ensure compliance with regulatory requirements.
🔍About the Role
As a Quality Control professional, you will play a critical role in ensuring the quality and integrity of clinical trials conducted by Samahitha.
Your primary responsibilities will include:
Audit Planning and Execution: Preparing audit plans, conducting audits, and generating audit reports for clinical trials and organisational structure.
Report Review: Reviewing monitoring reports, protocols, informed consents, and study reports to ensure compliance with regulatory requirements.
Audit Support: Attending external audits/inspections and suggesting corrective action plans for audit findings.
Regulatory Compliance: Participating in the collection and update of national and international laws, rules, and guidelines governing clinical trials.
SOP Development and Maintenance: Reviewing, creating, and updating Standard Operating Procedures (SOPs) and Standard Forms (SFs) applicable to the QC function.
🎓Requirements
Experience: 1 year of experience in Quality Control, preferably in a clinical research setting.
Clinical Operations Knowledge: Strong understanding of clinical operations, including Good Clinical Practice (GCP) and regulatory requirements.
Skills:
Excellent analytical and problem-solving skills.
Strong attention to detail and organisational skills.
Good communication and interpersonal skills.
💼What We Offer
Career Growth: Opportunities for professional development and growth in a leading clinical research organisation.
Collaborative Environment: A dynamic and supportive team environment.
Competitive Benefits: Competitive salary and benefits package.
🌐Why Choose Samahitha?
Industry Leader: Opportunity to work with a leading clinical research organisation.
Professional Development: Opportunities for professional growth and development.
Innovative Culture: A company that values innovation, quality, and people.
📩 Interested?
Send your resume to career@samahitha.com