Requirement | Analytical Method - Validation Analyst / Sr. Analyst

Marksans Pharma; Poriebhat; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Marksans Pharma Ltd. in Goa Verna seeks an Analytical Method Validation Analyst / Sr. Analyst with 4–5 years of experience in a regulated pharma setting. You will perform validation, method transfer, and related investigations, ensuring data integrity and cGMP/GLP compliance.

The role requires hands-on use of HPLC/UPLC, GC, dissolution, UV-Vis, KF, and CDS software like Empower 3 or Chromeleon, aligned with ICH Q2(R1/R2) and Q14 guidelines.

Qualifications

• B.Sc. or M.Sc. in Analytical Chemistry or M.Pharm or related field.
• 4–5 years of core experience in Analytical Method Validation in a regulated pharma company.
• Expertise in method validation and transfer; OOS/OOT investigations.

Responsibilities

• Perform method validation and transfer activities for drug substances and dosage forms (liquids, tablets, creams, suspensions).
• Lead investigations into OOS/OOT results during validation.
• Ensure data integrity and cGMP/GLP compliance in all laboratory work.
• Hands-on chromatography systems ( Empower 3, Chromeleon) and QC testing.

Skills

Analytical method validation

OOS/OOT investigations

Data integrity (ALCOA+)

cGMP/GLP compliance

ICH Q2/R1/R2 and Q14 familiarity

Education

B.Sc./M.Sc. in Analytical Chemistry / M.Pharm or related field

Tools

HPLC/UPLC

GC

Dissolution apparatus

UV-Vis

Karl Fischer (KF)

Empower 3

Chromeleon

Job description

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 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.