Quality Control Associate – Compliance (Biologics)
Location: Hyderabad, India
Employment Type: Full-Time
Work Model: On-Premise
Department: Quality Control – Compliance
Business Unit: Biologics
A leading global pharmaceutical organization, Dr. Reddy’s Laboratories, is seeking a Quality Control Associate – Compliance to strengthen Quality Management Systems (QMS), regulatory adherence, and audit readiness within its Biologics division. This role is critical in ensuring GMP compliance, documentation accuracy, and continuous quality improvement in a regulated manufacturing environment.
Job Overview
The Quality Control Associate – Compliance is responsible for ensuring that all QC laboratory operations align with internal quality standards and global regulatory expectations. The role involves managing change controls, CAPAs, SOP revisions, deviation tracking, and supporting internal and external audits.
This position is ideal for professionals with hands-on experience in regulated QC/QA environments, strong documentation expertise, and familiarity with GMP-driven quality systems.
Key Responsibilities
Change Control Management
Initiate, assess, and track change controls related to QC processes, instruments, and documentation
Conduct impact assessments and ensure timely implementation of approved changes
SOP & STP Management
Review, revise, and maintain Standard Operating Procedures (SOPs) and Standard Test Procedures (STPs)
Collaborate with QC and QA teams to ensure documentation accuracy and regulatory compliance
CAPA & Deviation Oversight
Support investigation, root cause analysis, and closure of CAPAs
Maintain complete documentation and effectiveness checks
Track deviations and quality events within QMS platforms
Quality Management System (QMS) Monitoring
Maintain and update QMS records including investigations and audit findings
Monitor timelines and ensure no overdue compliance actions
Escalate potential delays and coordinate cross-functional resolution
Audit & Inspection Readiness
Support preparation for internal and regulatory audits (FDA, EMA, etc.)
Participate in inspection activities and documentation reviews
GEMBA Inspections
Conduct routine on-floor GEMBA walks to assess QC operations
Identify compliance gaps and ensure corrective action implementation
Experience Level: Mid-Level
Experience Required:
4–7 years of experience in a regulated Quality Control or Quality Assurance environment
Strong exposure to GMP guidelines and regulatory standards (FDA, EMA, ISO)
Hands-on experience managing QMS elements such as CAPA, change control, deviations, and documentation systems
Experience in biologics or sterile manufacturing environment preferred
Educational Qualification
Bachelor’s degree in Life Sciences, Chemistry, Microbiology, or related scientific discipline
Technical Skills & Competencies
Strong knowledge of Good Manufacturing Practices (GMP) and regulatory compliance frameworks
Proficiency in QMS platforms and document control systems (LIMS, SAP, or equivalent)
Strong attention to detail and documentation accuracy
Ability to manage multiple compliance timelines simultaneously
Strong analytical and problem-solving skills
Effective communication and cross-functional collaboration skills
Behavioral Competencies
Self-driven and proactive approach
Strong team collaboration mindset
Excellent written and verbal communication skills
About the Organization
Dr. Reddy’s Laboratories is a multinational pharmaceutical company operating across 60+ countries with strong capabilities in API, formulations, biologics, regulatory affairs, and clinical development. The organization is committed to accelerating access to affordable and innovative medicines while maintaining robust corporate governance and sustainability standards.
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