Data Reviewer I

Sun Pharma is the world’s fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology.

Job Summary:

We are seeking a highly detail-oriented Data Reviewer to support Quality Assurance oversight of Quality Control laboratory activities. In this critical role, you will perform comprehensive reviews of scientific data and laboratory documentation to ensure accuracy, integrity, compliance, and audit readiness within a cGMP-regulated pharmaceutical environment.

This position is ideal for a quality-focused professional who enjoys analytical review, data integrity oversight, regulatory compliance, and working closely with laboratory operations to ensure the highest standards of quality are maintained.

What You'll Do

Scientific Data Review & Compliance

• Perform thorough, in-depth reviews of Quality Control laboratory documentation and scientific data for completeness, accuracy, integrity, and compliance.
• Review laboratory records including:
  • In-process testing data
  • API and excipient testing records
  • Finished product testing records
  • Stability study data
  • Cleaning verification results
  • Instrument calibration records
  • Contract laboratory reports
  • Regulatory submission support documentation (including ANDA-related materials)
• Verify that all laboratory activities and records comply with applicable cGMP requirements and site procedures.

Data Integrity Oversight

• Review audit trails and electronic data generated through computerized GxP laboratory systems.
• Ensure laboratory documentation adheres to ALCOA++ Data Integrity principles.
• Identify discrepancies, inconsistencies, or compliance concerns and escalate findings as appropriate.
• Support efforts to maintain data reliability, traceability, and regulatory compliance.

Quality Systems & Regulatory Support

• Maintain Quality Assurance oversight of Quality Control functions to ensure continuous inspection and audit readiness.
• Ensure documentation complies with:
  • cGMP requirements
  • Internal SOPs
  • USP, BP, and EP compendial requirements
  • ICH guidance
  • FDA and other applicable regulatory expectations
• Support departmental goals, quality initiatives, and continuous improvement activities.
• Assist with audit preparation and support regulatory inspections as needed.

Cross-Functional Collaboration

• Partner with Quality Control, Quality Assurance, and laboratory personnel to resolve documentation and compliance issues.
• Provide guidance and feedback regarding laboratory documentation practices and data integrity expectations.
• Perform additional assignments and special projects as directed by Quality Management.

Work Environment

This role operates primarily in an office environment with periodic interaction within laboratory operations.

The position may involve:

• Review of paper and electronic laboratory records
• Interaction with laboratory and quality personnel
• Exposure to laboratory operations and testing environments
• Moderate office and laboratory noise levels

Physical Requirements

• Frequent sitting and computer-based work.
• Regular use of hands and arms to perform data review and documentation activities.
• Occasional standing, walking, bending, stooping, kneeling, or crouching when visiting laboratory areas.
• Close vision, distance vision, color vision, and the ability to adjust focus.
• Ability to lift and/or move up to 10 pounds.

Travel: Up to 5%

What You Bring

Education

• Bachelor's degree required.

Technical Knowledge

• Strong understanding of pharmaceutical analytical testing and laboratory operations.
• Knowledge of cGMP and GLP requirements for analytical laboratories.
• Familiarity with:
  • USP, ICH, FDA, and DEA regulations
  • Data Integrity requirements and ALCOA++ principles
  • Laboratory documentation practices
  • Audit trail review processes
• Knowledge of analytical instrumentation including:
  • HPLC (including Empower data acquisition software)
  • GC
  • FTIR
  • UV/Visible Spectroscopy
  • Malvern Particle Size Analyzers
  • Wet chemistry techniques

Professional Skills

• Strong analytical and critical-thinking abilities.
• Exceptional attention to detail and documentation review skills.
• Excellent written, verbal, and presentation skills.
• Ability to work independently with minimal supervision.
• Strong organizational and time management skills.
• Self-motivated with a proactive, hands-on approach and a commitment to quality.
• English language proficiency at CEFR Intermediate B1+ level.

Experience

• Minimum 3 years of experience in a pharmaceutical environment.
• Minimum 2 years of hands-on chromatography experience, including:
  • HPLC (Empower preferred)
  • GC
  • FTIR
  • UV Spectroscopy
  • Wet chemistry techniques
• Experience reviewing laboratory records and supporting compliance activities in a regulated environment preferred.

Why Join Us?

• Play a vital role in ensuring the integrity and compliance of pharmaceutical laboratory data.
• Work closely with Quality Assurance and Quality Control teams in a highly regulated environment.
• Develop expertise in data integrity, regulatory compliance, and laboratory quality systems.
• Gain exposure to audit readiness initiatives and regulatory inspections.
• Join a collaborative organization committed to quality, compliance, and continuous improvement.

If you are passionate about quality, scientific accuracy, and data integrity, we invite you to apply and help ensure the highest standards of compliance and excellence across our laboratory operations.