What are the responsibilities and job description for the Data Reviewer I position at SUN PHARMA?
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
This role operates primarily in an office environment with periodic interaction within laboratory operations.
The Position May Involve
What You Bring Education
The presently-anticipated base compensation pay range for this position is $65,000 to $77,000. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Long Term Incentive Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.
The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
Notice To Agency And Search Firm Representatives
Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.
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.
- 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.
- 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.
- 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.
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
- 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.
What You Bring Education
- Bachelor's degree required.
- 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
- 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.
- 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.
- 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.
The presently-anticipated base compensation pay range for this position is $65,000 to $77,000. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Long Term Incentive Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.
The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
Notice To Agency And Search Firm Representatives
Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.
Salary : $65,000 - $77,000