Quality Control Analyst
- Glenmark
- 3 - 5 years
- 2 hours ago
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Job Description
Group Company: Glenmark Healthcare Limited
Designation: Senior Officer
Office Location: Dindori, Nashik
Position description: QualityControl Analyst
Primary Responsibilities:
To follow the instructions and directions given by the reportingauthorities for timely completion of assigned task.
To receive and analyse Semi-finished products, finished products,Process Validation and Miscellaneous samples as per respective currentspecification, standard testing procedures, SOP and record the observationonline in the test data sheet accordingly keeping in view of cGLP, cGMP
To destroy the tested samples in time after consultation with reportingauthorities and record the same in test data sheet.
To perform online monitoring of chromatograms and report timely for anyobservation related to OOS and OOT during analysis.
To perform analysis with zero error by using clean glassware and keepingin view of all safety parameters with respect to current SOP and specification.
To inform the reporting authorities well in advance for the procurementof the HPLC column, Chemicals, Glassware etc.
To ensure working area / instruments cleanliness and proper labelling onvolumetric flasks, instrument status tag and proper filing of documents atdesignated place.
Online recording of analysis on Test data sheet
To receive and analyze the samples of Raw/Packing Material as per theStandard test Procedure
To update logs related to Sample Receiving, Sampling and Testing ofRaw/Packing Materials and related Control Samples To paste labels of thesample containers as per status of the Raw/Packing Materials (i.e. Sampled /Approved / Rejected).
To operate instruments like HPLC, KF, Potentiometer Titrator and FTIRetc. as per the respective Standard Operating Procedure.
To perform calibration of all QC instruments as per the schedule andmaintaining their records
prepare working standards as per the requirement and maintaining theirrecords.
To prepare and standardize the Volumetric Solutions, Test SolutionsReagents as per standard procedures/protocols.
To comply various Acts and rules related to protection of environmentlike:
Hazardous and other Waste (Management and Trans-Boundary Movement) Rule2016/ / Environment (protection)Rules, 1986/ Noise Pollution (Regulation and Control) Rules, 2000/ E-waste(Management and Handling) Rules, 2011/ Water (Prevention and Control ofPollution) 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 orDepartment 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 withouterrors (analytical or documentation) on the first attempt.
Out of Specification (OOS) Rate: Frequency of test results fallingoutside pre-defined specifications.
Documentation/Data Integrity Accuracy: Error rate in lab notebooks, LIMS(Laboratory Information Management Systems) entries, and raw data, complyingwith ALCOA+ principles.
Audit Findings: Number of findings or observations directly attributableto 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 aglobal leader in the development and commercialization of generic drugs of thehighest quality and value. We help to improve peoples lives every day byhelping to reduce their healthcare costs while delivering high-qualitymedicines.
Established in 2023as a subsidiary of Glenmark Pharmaceuticals, we launched our first product in March2024 and quickly emerged as one of the leading organizations in India.
This jobdescription is to serve as a guide. It is intended to be flexible and willcontinue to evolve over time with business needs and demands and may be updatedperiodically and at the Companys discretion. Nothing in this positiondescription changes or is intended to change the employment at-willrelationship with the Company. Employment at-will means that an employee or theCompany may terminate the employment relationship at any time, for any reasonor no reason at all, with or without notice.
GlenmarkPharmaceuticals is proud to be an equal opportunity workplace and is anaffirmative action employer. We are committed to equal employment opportunityregardless of race, color, ancestry, religion, sex, national origin, sexualorientation, age, citizenship, marital status, disability, gender identity orVeteran status.
Specific requirements
- Travel: NA
- Vehicle: NA
- Work Permit: Valid to work in India
Other details
- Pay Rate:
- An individuals 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
Job Classification
Industry: BPM / BPOFunctional Area / Department: Quality AssuranceRole Category: Business Process QualityRole: Quality AnalystEmployement Type: Full timeContact Details:
Company: GlenmarkLocation(s): Dindori+ View Contact
Keyskills: method validation potentiometer sap software testing presentation skills quality control analysis data integrity analytical chemistry cfr hplc qc oos operations sop quality assurance writing sterile communication skills finished products
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Glenmark Pharmaceuticals Limited is a research-led, global organization committed to enriching lives. Innovation is deeply embedded in Glenmark??s culture; it is how we differentiate ourselves in our key markets and create greater value for our stakeholders.
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