Requirement | Analytical Method - Validation Analyst / Sr. Analyst

Marksans Pharma Ltd.; Poriebhat; On-site; INR 600,000 - 900,000; Full time

Job summary

Marksans Pharma Ltd. in Goa Verna seeks an Analytical Method Validation Analyst/Sr. Analyst to drive method validation activities for drug substances and finished dosage forms.

The role requires leadership in OOS/OOT investigations and hands-on use of HPLC/UPLC and GC, ensuring data integrity in a strict cGMP/GLP setting. The candidate should have a B.Sc./M.Sc. in Analytical Chemistry or M.Pharm (or related) and 4–5 years of core experience in analytical method validation within a regulated

Qualifications

• Experience in method validation of drug substances and dosage forms.
• OOS/OOT investigations during validation.
• Exposure to ICH Q2(R1/R2), ICH Q14, USP/EP requirements.

Responsibilities

• Perform activities pertaining to method validation and transfer for drug substances and various dosage forms.
• Lead investigations into OOS/OOT results during validation.
• Validate studies including specificity, linearity, accuracy, precision, LOD/LOQ, and robustness.
• Preparation of Analytical Method Validation or Transfer Protocols and Reports.
• Ensure all lab work adheres to ALCOA+ data integrity principles.

Skills

HPLC/UPLC

GC

Dissolution

Data integrity

cGMP/GLP

Education

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

Tools

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 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.

Regards,

Audrey Fernandes

Asst. Manager-HR