Senior Officer - Quality Control
Sun Pharmaceuticals, Inc
**Job Summary:**
The QC Analyst is responsible for performing analytical testing of raw materials, in-process samples, and finished pharmaceutical products to ensure compliance with USFDA regulations, cGMP standards, and internal specifications. This role is critical in maintaining product quality, safety, and efficacy.
**Key Responsibilities:**
+ **Analytical Testing:**
+ Conduct chemical, physical, and microbiological tests using techniques such as HPLC, GC, UV-Vis, FTIR, titration, and dissolution.
+ Perform stability studies and method validation as per regulatory guidelines.
+ **Documentation & Compliance:**
+ Maintain accurate and complete records of all testing activities in compliance with GDP.
+ Document and investigate any Out-of-Specification (OOS) results.
+ Ensure adherence to cGMP, GLP, and USFDA regulations.
+ **Equipment Handling:**
+ Calibrate, maintain, and troubleshoot laboratory instruments.
+ Ensure proper usage and upkeep of analytical equipment.
+ **Cross-Functional Collaboration:**
+ Coordinate with Production, QA, and R&D teams to resolve quality issues.
+ Participate in internal and external audits.
+ **Continuous Improvement:**
+ Assist in developing and validating new analytical methods.
+ Recommend improvements to testing procedures and quality systems.
**Qualifications:**
+ Bachelors or Masters degree in Chemistry, Pharmaceutical Sciences, or related field.
+ 25 years of experience in a pharmaceutical QC laboratory, preferably in a USFDA-approved facility.
+ Hands-on experience with analytical instruments and techniques.
+ Knowledge of regulatory guidelines (USFDA, ICH, WHO).
+ Strong attention to detail and analytical skills.
**Preferred Certifications:**
+ Certified Quality Analyst (CQA)
+ Training in cGMP, GLP, and data integrity
**Soft Skills:**
+ Excellent communication and documentation skills
+ Ability to work independently and in a team
+ Problem-solving and critical thinking abilities
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.
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