01 Aug
|
Par Health
|
Pudupakkam
01 Aug
Par Health
Pudupakkam
**Job Description Summary** QC Analyst with 3-6 years of experience in pharmaceutical quality control, skilled in routine in-process samples, and finished products. Experienced in instrumental analysis (HPLC, GC, UV, Dissolution), method execution as per approved SOPs, OOS/OOT investigations, and data integrity compliance. Well-versed in GMP, documentation practices, and regulatory guidelines, with robust analytical and problem-solving skills. **Job Description** + Perform routine QC testing of raw materials, intermediates, and finished products using approved analytical methods. + Conduct instrumental analysis including HPLC, GC, UV-Vis, Dissolution, and wet chemistry techniques. + Execute stability studies, compile data, trend results, and prepare stability reports. + Review and ensure accuracy, completeness, and compliance of analytical data and documentation. + Handle OOS, OOT, deviations, and laboratory incidents, including root cause analysis and implementation of CAPAs. + Ensure compliance with cGMP, data integrity (ALCOA+), SOPs,
and regulatory guidelines. + Support method transfers, method verifications, and analytical method validations as required. + Maintain laboratory equipment, perform calibrations, and ensure proper documentation of laboratory activities. + Participate in internal audits, regulatory inspections, and continuous improvement initiatives. + Coordinate with cross-functional teams such as QA, Manufacturing, and Regulatory Affairs as needed. + Proficiency in laboratory documentation and electronic systems (LIMS preferred). + Good problem-solving, analytical, and communication skills. + Ability to work independently as well as collaboratively in a regulated environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
📌 Analyst, Global Stability (Pudupakkam)
🏢 Par Health
📍 Pudupakkam