MakroCare Hiring Clinical Quality Assurance (CQA) Associate in Hyderabad
MakroCare is actively seeking a Clinical Quality Assurance (CQA) Associate to join its Hyderabad team. This role is critical in ensuring adherence to international standards and regulatory requirements in clinical research processes. If you have a background in life sciences and experience in quality assurance, this could be the perfect career move for you.
Job Overview
Position: Clinical Quality Assurance (CQA) Associate
Location: Hyderabad, Telangana, India
Job Type: Full-time, On-site
Department: QA – MakroCare and DDi
Experience: 2-4 years in Clinical Quality Assurance or related fields
This role offers an excellent opportunity to work in a dynamic, fast-growing company where compliance, quality management, and regulatory adherence are paramount. MakroCare is well-known for delivering high-quality clinical research services, and your contribution as a CQA Associate will ensure that these standards are upheld.
Key Responsibilities
As a CQA Associate at MakroCare, your primary duties will include:
- Perform maintenance, review, and approval of company Standard Operating Procedures (SOPs) in compliance with ISO standards and applicable international and national regulations
- Prepare and review Quality Management System (QMS) documents, CQA procedures, and assist in reviewing department SOPs as needed.
- Manage SOPs in mLMS, create users, review training records, and escalate non-compliance issues to the Head of CQA or relevant department heads.
- Maintain the CQA document repository and archive validation protocols and documents in line with regulatory requirements.
- Conduct internal audits of Clinical Research Department activities and ISO requirements, ensuring compliance with ICH-GCP and company procedures.
- Provide training to staff on ISO standards and local regulations when necessary.
- Control and manage documents, including maintaining master lists and issuing change controls, deviations, CAPAs, amendments, and notes to file.
- Update logs for change control, deviations, CAPAs, amendments, and NTFs.
- Prepare annual CQA reports and trend analysis, and assist with external audits from clients, certification bodies, or regulatory authorities.
This role is highly focused on ensuring the quality and compliance of clinical research operations, making it essential for candidates with a meticulous attention to detail and a deep understanding of regulatory frameworks.
Qualifications and Requirements
To be considered for the Clinical Quality Assurance Associate position, candidates must meet the following criteria:
- Education: A Bachelor’s or Master’s degree in Life Sciences or a related field is required.
- Experience: 2-4 years of relevant experience in Clinical Quality Assurance or a similar role, with a strong understanding of ISO regulations, ICH-GCP guidelines, and QMS.
- Skills: Knowledge in GCP, CAPAs, clinical quality management, SOP management, deviations, and compliance.
- Auditing Experience: Previous experience in conducting internal audits and managing regulatory documentation is highly preferred.
This is a highly responsible role, so familiarity with ISO standards, QMS processes, and clinical research protocols is crucial. If you are detail-oriented and thrive in a compliance-focused environment, MakroCare welcomes you to apply.
How to Apply
Interested candidates are encouraged to submit their applications as soon as possible – Apply on Linkedin
To apply for this job please visit www.linkedin.com.
