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Quality Assurance Reviewer
2 months ago
Job Overview
Sun Pharma is seeking a highly skilled Quality Assurance Reviewer to join our team. As a key member of our Quality Assurance department, you will be responsible for performing critical in-depth reviews of scientific data for Quality Control laboratory documents.
Key Responsibilities
- Perform critical in-depth review of all scientific data for Quality Control laboratory documents for completeness, integrity, and accuracy.
- Demonstrate a thorough knowledge of approved SOPs, compendia, ICH, FDA, and other regulatory guidances.
- Ensure that all documents are in compliance with cGMPs and the site operating procedures under the direction of QA management.
- Support systems to ensure the successful completion of Departmental goals and objectives.
- Other tasks as assigned by the Manager.
Work Conditions and Physical Requirements
This role will require working in an office environment and occasionally visiting the lab environment. The employee is frequently required to sit, use hands to finger, handle objects, or feel objects, tools, or controls, and reach with hands and arms. The employee is occasionally required to stand, stoop, kneel, and crouch. Specific vision abilities required for this job include close vision, distance vision, color vision, and the ability to adjust focus.
Education and Job Qualifications
- Minimum of a Bachelor's degree.
- Knowledge of pharmaceutical analysis.
- Ability to review laboratory records with minimal supervision within the framework of cGMP/GLP for analytical laboratories.
- Good understanding of EHS and OSHA safety guidelines.
- Knowledge of USP, ICH, FDA, and DEA regulations.
- Knowledge of the operating principles of HPLC, UV, FTIR, GLC, and Malvern particle size analyzers.
- Demonstrated excellent communication: verbal, written, and presentation skills.
- A self-starter with a hands-on approach and a can-do attitude.
- The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).
Experience
- Minimum of three years of experience in a pharmaceutical environment with a minimum two years of experience in chromatography (e.g. HPLC with empower data acquisition software, GC, FTIR, UV, and wet chemistry).
Compensation and Benefits
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 Employees are eligible to participate in Company employee benefit programs which include medical, dental, and vision coverage; life insurance; disability insurance; (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.
