Sr. Executive-QC-AMV

Keka Inc.; Dharwad District; On-site; INR 600,000 - 900,000; Full time

Job summary

Keka Inc. is seeking a Senior Executive – QC (AMV) to plan, coordinate, and execute analytical method verification for pharmacopoeial and other validated methods prior to routine laboratory use.

The role includes preparing Protocols and Reports, assessing method suitability for products and lab conditions, and ensuring data integrity and regulatory compliance. It also covers finished product testing, stability samples, and audit readiness.

Qualifications

• Degree in pharmaceutical science or chemistry with relevant coursework in analytical chemistry.
• 3–4 years of experience in a pharmaceutical QC laboratory focusing on analytical testing, data review and method verification.
• Experience with regulatory expectations and pharmacopoeial compliance preferred.

Responsibilities

• Plan, coordinate and execute analytical method verification for pharmacopoeial and validated methods prior to routine use.
• Prepare and review Method Verification Protocols and Reports in line with approved procedures and regulatory requirements.
• Assess method suitability for product, formulation, equipment, and lab conditions.
• Verify applicable analytical methods and data integrity during verification.
• Perform analytical testing of finished product and stability samples per approved specs.
• Review sample identification, batch details, sampling information and test requirements.
• Ensure instruments are qualified and within calibration/maintenance status.
• Ensure testing is against current approved specification and Method of Analysis.
• Periodically review and trend stability data for critical quality attributes.
• Ensure alignment with IP, USP, BP, Ph. Eur. pharmacopoeias and other applicable requirements.
• Prepare for audits and inspections and support training.

Skills

Analytical Method Verification

Data Review

Regulatory Compliance

OOS/OOT Investigation

Education

B.Pharm/M.Pharm/B.Sc/M.Sc in Chemistry

Tools

HPLC

Spectroscopy

Job description

A Senior Executive – QC (AMV) is required to plan, coordinate, and execute analytical method verification activities for pharmacopoeial and other validated analytical methods prior to their routine implementation in the laboratory. The role is responsible for the preparation, review, and approval coordination of Method Verification Protocols and Reports in compliance with approved procedures, data integrity principles, and applicable regulatory requirements. Additionally, the position will be responsible for assessing method suitability and performance with respect to specific products, formulations, analytical instruments, and laboratory operating conditions to ensure reliable, accurate, and compliant analytical results

Analytical Method Verification, Finished Product & Strength Testing

1. Analytical Method Verification

• Plan, coordinate and execute analytical method verification for pharmacopoeial and other validated methods prior to routine use.
• Prepare and review Method Verification Protocols and Reports in accordance with approved procedures and applicable regulatory requirements.
• Assess method suitability for the specific product, formulation, equipment and laboratory conditions.
• Verify applicable analytical.

2. Finished Product Analytical Testing

• Perform analytical testing of Finished Products in accordance with approved specifications and Methods of Analysis.
• Ensure testing is performed using current approved analytical procedures and qualified/calibrated instruments.
• Review sample identification, batch details, sampling information and test requirements before analysis.

3. Stability Sample Testing

4. Analytical Data Review & Data Integrity

5. OOS / OOT / Atypical Result Investigation

6. Laboratory Instrument & Equipment Compliance

• Ensure instruments used for finished product and stability testing are qualified and within valid calibration/maintenance status.

7. Method & Specification Compliance

• Ensure all testing is performed against the current approved specification and Method of Analysis.

8. Stability Trend Analysis

• Periodically review and trend stability data for critical quality attributes.

9. Regulatory & Pharmacopoeial Compliance

• Ensure analytical testing is aligned with applicable requirements of IP, USP, BP, Ph. Eur. and other applicable pharmacopoeias, as relevant to the product and market.

10. Audit & Inspection Readiness

11. Training & Technical Development

Qualifications & Experience Required:

Degree:

B.Pharm, M.Pharm, B.Sc, or M.Sc. in Chemistry, Organic Chemistry,

Analytical Chemistry.

Experience :

3 to 4 years of relevant work experience in a pharmaceutical QC

laboratory, with a distinct focus on analytical testing, data review,

analytical method verification and compliance