Professionals looking for Clinical Quality Assurance jobs in Hyderabad have an excellent opportunity with Aizant Drug Research Solutions Pvt. Ltd. The company is currently recruiting experienced candidates for the position of Clinical QA – Bioanalytical Quality Assurance (BA/BE Studies) at its Dulapally, Hyderabad facility.
This opportunity is ideal for candidates with experience in bioanalytical quality assurance, regulatory compliance, BA/BE studies, quality management systems, audit management, and CAPA processes. Candidates from pharmacy, life sciences, biotechnology, microbiology, biochemistry, and related scientific backgrounds are encouraged to apply.
As regulatory expectations continue to increase across the pharmaceutical and clinical research sectors, skilled Clinical QA professionals play a critical role in ensuring compliance, data integrity, and quality oversight throughout bioanalytical and clinical research operations.
Job Overview
Position: Clinical QA – Bioanalytical Quality Assurance (BA/BE Studies)
Company: Aizant Drug Research Solutions Pvt. Ltd.
Location: Dulapally, Hyderabad, Telangana, India
Experience Required: 3–5 Years
Qualification: B.Pharm, M.Pharm, M.Sc, Life Sciences, Biotechnology, Biochemistry, Microbiology, Pharmacology, Pharmacy Practice, Clinical Research, Pharmaceutical Analysis, or equivalent scientific qualification
Industry: Clinical Research Organization (CRO)
Employment Type: Full-Time
About Aizant
Aizant Drug Research Solutions Pvt. Ltd. is a leading Contract Research Organization providing integrated services in pharmaceutical research, bioanalytical services, clinical research, formulation development, regulatory support, and manufacturing solutions.
The company serves global pharmaceutical and biotechnology clients while maintaining stringent regulatory compliance standards. Aizant’s Clinical Quality Assurance division supports quality systems, regulatory inspections, audit management, and data integrity programs aligned with international standards.
Roles and Responsibilities
Audit and Compliance Activities
- Conduct in-process audits of bioanalytical studies and laboratory activities.
- Perform retrospective audits of completed bioanalytical studies.
- Verify compliance with approved protocols and SOPs.
- Participate in quality oversight across bioanalytical operations.
- Ensure adherence to GLP, GCP, and regulatory requirements.
Bioanalytical Data Review
- Review and approve subject concentration data.
- Verify data integrity before pharmacokinetic and biostatistical analysis.
- Review laboratory records and analytical documentation.
- Support quality assessment of study data and reports.
Equipment and Laboratory Oversight
- Review laboratory instrument qualification records.
- Verify calibration and maintenance documentation.
- Assess laboratory readiness and operational compliance.
- Ensure analytical instruments meet quality requirements.
Quality Systems Management
- Perform facility inspections and laboratory walkthroughs.
- Monitor SOP compliance and quality systems implementation.
- Review controlled documents and quality records.
- Support continuous quality improvement initiatives.
CAPA and Audit Observation Management
- Review audit findings and observations.
- Monitor CAPA implementation and effectiveness.
- Support timely closure of quality observations.
- Maintain audit documentation and quality records.
Required Qualifications
Candidates should possess any of the following qualifications:
- B.Pharm
- M.Pharm
- M.Sc
- Life Sciences
- Biotechnology
- Biochemistry
- Microbiology
- Pharmacology
- Pharmacy Practice
- Pharmaceutical Analysis
- Clinical Research
- Equivalent Scientific Qualification
Experience Required
Applicants should have:
- 3 to 5 years of experience in Bioanalytical Quality Assurance
- Experience in BA/BE studies
- Exposure to regulated clinical research environments
- Experience handling audits and compliance activities
Required Skills
Successful candidates should have knowledge of:
- Bioanalytical Quality Assurance
- BA/BE Regulatory Guidelines
- Good Laboratory Practices (GLP)
- Good Clinical Practices (GCP)
- Quality Management Systems (QMS)
- CAPA Management
- Audit Management
- Data Integrity Principles
- Regulatory Compliance
- Documentation Control
- Clinical Research Quality Systems
Preferred Candidate Profile
The ideal candidate should possess:
- Strong understanding of GLP and GCP requirements
- Experience in bioanalytical laboratory quality systems
- Knowledge of CAPA processes and audit observations
- Experience reviewing analytical and study-related data
- Strong communication and documentation skills
- Ability to work effectively in cross-functional teams
Salary and Benefits
Estimated Salary: ₹5.5 LPA – ₹9.5 LPA
Benefits may include:
- Competitive compensation package
- Career growth opportunities in Clinical QA
- Exposure to global regulatory standards
- Learning and development opportunities
- Professional growth in regulatory compliance and quality systems
- Collaborative scientific work environment
Actual salary will depend on experience, skills, current compensation, and company policies.
Why Join Aizant?
A career with Aizant offers professionals the opportunity to:
- Work in a reputed Contract Research Organization
- Gain exposure to international regulatory standards
- Build expertise in BA/BE quality systems
- Participate in audit and compliance programs
- Enhance knowledge of bioanalytical operations
- Develop long-term careers in Clinical QA and Regulatory Compliance
- Work with multidisciplinary scientific teams
How to Apply
Interested and eligible candidates can share their updated resumes directly with the recruitment team.
Email: sonyjeevitha.degala@aizant.com
Important Details to Mention
Candidates should include the following information in their application:
- Current CTC
- Expected CTC
- Notice Period
- Total Relevant Experience
Applicants are advised to highlight their Bioanalytical QA experience, audit exposure, quality systems expertise, and BA/BE study involvement in their resumes.