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Macleods Pharmaceutical Ltd has announced an exciting opening for the Clinical QA profile in the Bioequivalence (BE) Department at its Ahmedabad facility. This role is ideal for experienced M.Pharm professionals who want to build their career in Clinical Quality Assurance, GCP compliance, SOP management, and clinical audits.
If you’re looking for a stable, growth-oriented opportunity with a leading Indian pharmaceutical company, this opening is worth exploring.
Key Responsibilities
As a Clinical QA Officer in the Bioequivalence Department, you will be responsible for:
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Quality Assurance & Compliance
- Conducting independent inspections and audits of clinical operations as per SOPs.
- Reviewing protocols for completeness, accuracy, and regulatory compliance.
- Ensuring adherence to GCP and regulatory standards.
- Verifying no deviations occur without authorization and documentation.
SOP & Documentation Management
- Preparing, reviewing, and implementing SOPs.
- Issuing BE-related documents and assisting in archiving raw data, SOPs, and study reports.
- Reviewing final biostudy reports to ensure accuracy of raw data and procedures.
Training & Personnel Development
- Conducting training sessions for new and existing staff on QA and auditing principles.
- Preparing training schedules and maintaining complete training records.
- Assisting QA personnel in post-training assessments.
- Coordinating training for contractual staff.
Facility & System Audits
- Conducting audits of clinical sections, pathology departments, and safety systems.
- Reviewing equipment calibration records.
- Scheduling continuous training programs with respective departments.
Required Qualifications
- Education: M.Pharm (Mandatory)
- Experience: 2–3 years in Clinical QA / BE QA / GCP Compliance
- Freshers are not eligible
Skills & Competencies
- Strong understanding of GCP, regulatory guidelines, bioequivalence studies
- Expertise in SOP development and review
- Good audit planning and documentation skills
- Excellent communication and training ability
- Detail-oriented with strong analytical thinking
Benefits of Working at Macleods Pharma
- Work with a leading Indian pharmaceutical giant
- Exposure to BE studies, GCP compliance, and high-quality systems
- Opportunity for career growth in Clinical QA & Regulatory
- Professional, structured work culture with continuous learning
How to Apply
Interested and eligible candidates can send their updated resume to:
📩 adityab@macleodspharma.com
📌 Subject Line: Application for Clinical QA – BE Department
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