Quality Control Analyst Full Time NEW

Group Company: Glenmark Healthcare Limited

Designation: Senior Officer

Office Location: Dindori, Nashik

Position description: Quality Control Analyst

Primary Responsibilities

• To follow the instructions and directions given by the reporting authorities for timely completion of assigned task.
• To receive and analyse Semi-finished products, finished products, Process Validation and Miscellaneous samples as per respective current specification, standard testing procedures, SOP and record the observation online in the test data sheet accordingly keeping in view of cGLP, cGMP
• To destroy the tested samples in time after consultation with reporting authorities and record the same in test data sheet.
• To perform online monitoring of chromatograms and report timely for any observation related to OOS and OOT during analysis.
• To perform analysis with zero error by using clean glassware and keeping in view of all safety parameters with respect to current SOP and specification.
• To inform the reporting authorities well in advance for the procurement of the HPLC column, Chemicals, Glassware etc.
• To ensure working area / instruments cleanliness and proper labelling on volumetric flasks, instrument status tag and proper filing of documents at designated place.
• Online recording of analysis on Test data sheet
• To receive and analyze the samples of Raw/Packing Material as per the Standard test Procedure
• To update logs related to Sample Receiving, Sampling and Testing of Raw/Packing Materials and related Control Samples & To paste labels of the sample containers as per status of the Raw/Packing Materials (i.e. Sampled / Approved / Rejected).
• To operate instruments like HPLC, KF, Potentiometer Titrator and FTIR etc. as per the respective Standard Operating Procedure.
• To perform calibration of all QC instruments as per the schedule and maintaining their records &
• prepare working standards as per the requirement and maintaining their records.
• To prepare and standardize the Volumetric Solutions, Test Solutions & Reagents as per standard procedures/protocols.
• To comply various Acts and rules related to protection of environment like:
• Hazardous and other Waste (Management and Trans-Boundary Movement) Rule 2016/ / Environment (protection) Rules, 1986/ Noise Pollution (Regulation and Control) Rules, 2000/ E-waste (Management and Handling) Rules, 2011/ Water (Prevention and Control of Pollution) Act,1974 amended 1988/ The Air (Prevention and control of pollution) Act 1981, amended 1987/ the Environment Protection act,1986
• IT Application: – MS Office STD, Melt View, EZ Chrome, LC Solution.
• To follow any other instruction Given by Reporting Authority or Department head.

Additional Responsibilities: NA

Reporting Team

• Reporting Designation: NA
• Reporting Department: Quality Control

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: Quality Control Analyst
• Years of experience: 03 to 05 Years

Key Performance Indicators

• Right First Time (RFT) Rate: Percentage of tests performed without errors (analytical or documentation) on the first attempt.
• Out of Specification (OOS) Rate: Frequency of test results falling outside pre-defined specifications.
• Documentation/Data Integrity Accuracy: Error rate in lab notebooks, LIMS (Laboratory Information Management Systems) entries, and raw data, complying with ALCOA+ principles.
• Audit Findings: Number of findings or observations directly attributable to the analyst during internal or external audits.

Required Competencies

• Analytical Chemistry Techniques
• Instrument Troubleshooting
• Data Integrity & Management
• Regulatory Compliance
• Method Validation & Transfer
• Attention to Detail
• Documentation Practices (GDP) & (GLP)
• Investigation & Troubleshooting
• Calibration

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