SUN PHARMA
Overview
Data Reviewer, Office of Data Reliability (ODR) is accountable for critical review of pre-submission applications ready for regulatory submission to the US FDA. Responsibilities include the review of assigned pre-submission applications by using department SOPs and exhaustive audit checklists to ensure Data Integrity, Reliability, Accuracy, and Traceability of any submitted data. Area Of Responsibility
Ensures compliance with cGMP/cGLP and good documentation procedure during the review process Audits regulatory pre-submission documents from the manufacturing and quality units within the purview of ODR checklist Communicates any audit comments/ observations/ findings to respective stakeholders and assesses acceptability/ appropriateness of responses Informs the manager/s and Chief Data Reliability Officer immediately of any critical data integrity issues or data irregularity Reports all audit finding in the ODR audit worksheets and highlight noteworthy/ major/ critical observations on CDRO certifications Completes the audit tasks within the specified timeframe without compromising the quality of the audit and archives all documents in a closed electronic system Colates audit findings in the audit comments log Performs any other responsibilities which are required as assigned by the manager/s depending on departmental needs Completes all training requirements as per Learning Management System (LMS) and as per Safety Adheres to the Safety and Health Program and associated plans. Work Conditions
Corporate office environment; Laboratory environment – QC and ARD. The ODR data reviewer will primarily work in an office environment reviewing copies of reference documents. Exposure to laboratory/manufacturing environments is minimal unless the reviewer needs to view concerns in person or discuss with stakeholders. Physical Requirements
In performance of tasks, the reviewer should be able to sit at a desk for long periods and work on the computer for most hours If needed, they must be able to navigate office, lab, and/or plant floor environments while adhering to safety protocols Must wear applicable PPE as required at the site (e.g., respirators, safety glasses/goggles, safety shoes) Education and Job Qualification
Minimum Bachelor of Science (B.S.) in Chemistry, Pharmacy, Biochemistry or related field. A Master of Science (M.S.) in Chemistry, Pharmacy, Biochemistry or related field is desirable. Knowledge of laboratory test procedures, cGMP/cGLP/cGDP requirements, ICH/US FDA guidelines, raw material analyses, method validation guidelines, analytical method transfers, finished products and stability testing procedures; SOPs and related procedures; manufacturing and packaging batch records; COAs; manufacturing reports; scale-up and product development reports; Quality summaries Proficient in MS Office applications (Word, Excel) Ability to monitor, coordinate and prioritize work, manage multiple projects within timelines Self-motivated, proactive team player with positive interaction with colleagues and stakeholders Professional conduct aligned with corporate values Ability to work and interact successfully in a global, diverse and dynamic environment Excellent verbal, written and presentation skills Strong project management and problem-solving skills English language proficiency: Intermediate-B1+ (CEFR) Experience
Minimum 5 years of experience in a pharmaceutical company within a cGMP environment in Quality Control and/or Analytical R&D Minimum 2 years of Quality Assurance exposure in Pharmaceutical industry, involving review of manufacturing/packaging batch records and investigations (desirable) Seniority level
Entry level Employment type
Full-time Job function
Manufacturing Industries
Pharmaceutical Manufacturing
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Data Reviewer, Office of Data Reliability (ODR) is accountable for critical review of pre-submission applications ready for regulatory submission to the US FDA. Responsibilities include the review of assigned pre-submission applications by using department SOPs and exhaustive audit checklists to ensure Data Integrity, Reliability, Accuracy, and Traceability of any submitted data. Area Of Responsibility
Ensures compliance with cGMP/cGLP and good documentation procedure during the review process Audits regulatory pre-submission documents from the manufacturing and quality units within the purview of ODR checklist Communicates any audit comments/ observations/ findings to respective stakeholders and assesses acceptability/ appropriateness of responses Informs the manager/s and Chief Data Reliability Officer immediately of any critical data integrity issues or data irregularity Reports all audit finding in the ODR audit worksheets and highlight noteworthy/ major/ critical observations on CDRO certifications Completes the audit tasks within the specified timeframe without compromising the quality of the audit and archives all documents in a closed electronic system Colates audit findings in the audit comments log Performs any other responsibilities which are required as assigned by the manager/s depending on departmental needs Completes all training requirements as per Learning Management System (LMS) and as per Safety Adheres to the Safety and Health Program and associated plans. Work Conditions
Corporate office environment; Laboratory environment – QC and ARD. The ODR data reviewer will primarily work in an office environment reviewing copies of reference documents. Exposure to laboratory/manufacturing environments is minimal unless the reviewer needs to view concerns in person or discuss with stakeholders. Physical Requirements
In performance of tasks, the reviewer should be able to sit at a desk for long periods and work on the computer for most hours If needed, they must be able to navigate office, lab, and/or plant floor environments while adhering to safety protocols Must wear applicable PPE as required at the site (e.g., respirators, safety glasses/goggles, safety shoes) Education and Job Qualification
Minimum Bachelor of Science (B.S.) in Chemistry, Pharmacy, Biochemistry or related field. A Master of Science (M.S.) in Chemistry, Pharmacy, Biochemistry or related field is desirable. Knowledge of laboratory test procedures, cGMP/cGLP/cGDP requirements, ICH/US FDA guidelines, raw material analyses, method validation guidelines, analytical method transfers, finished products and stability testing procedures; SOPs and related procedures; manufacturing and packaging batch records; COAs; manufacturing reports; scale-up and product development reports; Quality summaries Proficient in MS Office applications (Word, Excel) Ability to monitor, coordinate and prioritize work, manage multiple projects within timelines Self-motivated, proactive team player with positive interaction with colleagues and stakeholders Professional conduct aligned with corporate values Ability to work and interact successfully in a global, diverse and dynamic environment Excellent verbal, written and presentation skills Strong project management and problem-solving skills English language proficiency: Intermediate-B1+ (CEFR) Experience
Minimum 5 years of experience in a pharmaceutical company within a cGMP environment in Quality Control and/or Analytical R&D Minimum 2 years of Quality Assurance exposure in Pharmaceutical industry, involving review of manufacturing/packaging batch records and investigations (desirable) Seniority level
Entry level Employment type
Full-time Job function
Manufacturing Industries
Pharmaceutical Manufacturing
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