Requirement | Analytical Method - Validation Analyst / Sr. Analyst

Job Title: Analytical Method Validation Analyst / Sr. Analyst
Experience: 4- 5 Years
Location: Marksans Pharma Ltd., Goa Verna
Qualification: B.Sc. / M.Sc. in Analytical Chemistry / M.Pharm or related field

Responsibilities:

• To perform activities pertaining to method validation and method transfer and routine analysis of the of drug substance and of liquid, tablets, cream, suspension dosage forms.
• Lead investigations into Out of Specification (OOS) and Out of Trend (OOT) results during the validation phase. Expert-level proficiency in HPLC/UPLC and GC. Familiarity with Dissolution apparatus, UV-Vis, and Karl Fischer (KF).
• Perform validation studies including Specificity, Linearity, Accuracy, Precision (Repeatability & Intermediate), LOD/LOQ, and Robustness.
• Enough understanding and exposure of Analytical test like Assay, Related Substances, Residual Solvents, Moisture Content, Dissolution of Drug Product.
• Experience in Analytical Method Transfer.
• Preparation of Analytical Method Validation or Transfer Protocol and Report.
• Any other job assigned by the assistant manager, Manager and HOD.
• Ensure all laboratory work is performed in a strict cGMP/GLP environment with 100% adherence to data integrity principles (ALCOA+).
• Hands-on experience with chromatography data systems like Empower 3 or Chromeleon.
• In-depth understanding of ICH Q2(R1/R2) and ICH Q14 guidelines. Familiarity with USP/EP compendial requirements.
• B.Sc. / M.Sc. in Analytical Chemistry, M.Pharm or a related field.
• 4 to 5 years of core experience in Analytical Method Validation within a regulated pharmaceutical company.

Interested Candidate may send their resume on email Id : [email protected]

Regards,

Audrey Fernandes

Asst. Manager-HR