Group Company: Glenmark Healthcare Limited

Designation: Senior Officer

Office Location: Dindori, Nashik

Position description: Quality Assurance Analytical Data Review

Primary Responsibilities: 

·         Review QC lab data, including chromatographic data and notebooks, for compliance with cGMP, GLP, and ICH guidelines.

·         Audit sample login, analytical worksheets, instrument logbooks, and Certificate of Analysis (COA) for accuracy.

·         Investigate Out of Specification (OOS) results, deviations, and laboratory inconsistencies.

·         Ensure laboratory analysts follow approved Standard Operating Procedures (SOPs) and validated test methods.

·         Coordinate with QC analysts to address data discrepancies, audit findings, and inspection queries.

·         Prepare, review, and revise SOPs, Specifications, and Analytical Method Validation (AMV) protocols.

·          

Key Qualifications

·         Education/Experience: Often requires a chemistry degree with experience in pharmaceutical laboratory data review.

Skillset:Analytical data review Experience GMP compliance, and analytical techniques.

·         To follow any other instruction Given by Reporting Authority or Department head. 

Additional Responsibilities: NA

Reporting Team

• Reporting Designation: Head QA

• Reporting Department: Quality Assurance

Educational qualifications preferred

• Category: Bsc, Msc, B.Pharm, M.Pharm

• Field specialization: Any

• Degree: Full time

• Academic score: Any

• Institution tier: Any

Required Certification/s: NA

Required Training/s: NA

Required work experience

• Industry: Pharmaceutical Industry

• Role: Analytical Data Review

• Years of experience: 03 to 05 Years

Key Performance Indicators: 

·         Analytical Development and Validation activity.

 ·    Analytical data review Experience.

Required Competencies: 

• Knowledge of operating sophisticated instruments like HPLC and GC, UV spectrophotometer, Auto titrator and review of analytical data .

 · Familiar with Quality control department process in pharmaceutical industry

Required Knowledge & Skills: 

• Fluent in English.

• A professional approach at all times.

• Excellent presentation, written and verbal communication skills, capable of interfacing with all levels in the company and stakeholders and with internal and external customers.

• An engaging, assertive nature with excellent inter-personal skills.

• A motivated self-starter, self-reliant and a strong, co-operative proactive team player capable of working in global teams, with strong influencing and negotiating capability, persistence and a strong determination.

• Experience of having Sterile operations is preferred.

• Knowledge of CFR.

• SAP or any other ERP system

Required abilities

• Physical: 

• The incumbent typically works in an office environment and uses a computer, telephone and other office equipment as needed to perform duties.

• The noise level in the work environment is typical of that of an office.

• Incumbent may encounter frequent interruptions throughout the workday.

• The incumbent is regularly required to sit, talk, or hear; frequently required to use repetitive hand motion, handle or feel, and to stand, walk, reach, bend or lift up to 20 pounds.

• Other: NA

Work Environment Details: 

Glenmark is a global leader in the development and commercialization of generic drugs of the highest quality and value. We help to improve people’s lives every day by helping to reduce their healthcare costs while delivering high-quality medicines.

Established in 2023 as a subsidiary of Glenmark Pharmaceuticals, we launched our first product in March 2024 and quickly emerged as one of the leading organizations in India.

This job description is to serve as a guide. It is intended to be flexible and will continue to evolve over time with business needs and demands and may be updated periodically and at the Company’s discretion. Nothing in this position description changes or is intended to change the employment at-will relationship with the Company. Employment at-will means that an employee or the Company may terminate the employment relationship at any time, for any reason or no reason at all, with or without notice.

Glenmark Pharmaceuticals is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Specific requirements

• Travel: NA

• Vehicle: NA

• Work Permit: Valid to work in India

Other details

• Pay Rate:

• An individual’s final compensation offer will be based on a variety of factors, including but not limited to education level, relevant experience, training, and geographic location. 

• Contract Types: Full Time Employee

• Time Constraints: NA

• Compliance Related: NA

• Union Affiliation: NA