12 Stability Testing Jobs

integration with labware LIMS, Previous responsibility: *Finished product section head: responsibility were, SFG, FP, Inprocess, cleaning samples planing for analysis, incident, deviations, Investigation, CAPA, Effectiveness monitoring and change management related to finished section. *timely releasing of products. *Raw material and packaging material section head, incident, deviations, Investigation, CAPA, Effectiveness monitoring and change management related RM/PM. *timely releasing of materials. *products validation and method transfer. *Stability section head, stability study protocol prepration, review, stability chamber management, monitoring of samples charging, timely analysis, stability summary report compilation, *Ensure timely closing of OOT, OOS, deviations. *regulatory affairs responce and products submitted queries responce. *Laboratory software audit trail review and compliance, safety management. If interested mail cv at : NeetiJ@selectsourceintl.com

Job Summary: Perform and report the analysis of In-Process samples, finished products, Stability samples and Cleaning Validation. Job Responsibilities: To ensure timely completion of analysis and data completion for the same. To be responsible for all activities in the Quality Control Laboratory, including cGLP, documentation and implementation of departmental quality systems. To perform the in-process/finish product/stability testing of laboratory Batches, Commercial batches, other stability samples and cleaning validation. To Prepare Stability Trend Reports for Laboratory samples. To collect and maintain various laboratory samples. To generate and maintain records related to laboratory samples. Works as a member of a team to achieve all outcomes. Performs all work in accordance with all established regulatory and compliance and safety requirements. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. To assist the Senior Analyst / Team Leader/Group Leader in the day-to-day functioning of the Quality Control Laboratory. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other duties as assigned. Job Requirements: Education M.Sc\BPham or any equivalent degree Knowledge, Skills and Abilities Effective command over verbal and written communication with good interpersonal skills. Command on Microsoft-Office (Word, Excel). Able to prioritize the tasks. Best in effective planning of work activities to meet the time lines. Experience Minimum 3 to 6 years of experience in GMP regulated pharmaceutical industry.

Job Summary: Perform and report the analysis of In-Process samples, finished products, Stability samples and Cleaning Validation. Job Responsibilities: To ensure timely completion of analysis and data completion for the same. To be responsible for all activities in the Quality Control Laboratory, including cGLP, documentation and implementation of departmental quality systems. To perform the in-process/finish product/stability testing of laboratory Batches, Commercial batches, other stability samples and Cleaning validation. To Prepare Stability Trend Reports for Laboratory samples. To collect and maintain various laboratory samples. To generate and maintain records related to laboratory samples. Works as a member of a team to achieve all outcomes. Performs all work in accordance with all established regulatory and compliance and safety requirements. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. To assist the Senior Analyst / Team Leader/Group Leader in the day-to-day functioning of the Quality Control Laboratory. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other duties as assigned. Job Requirements: Education M.Sc\BPham or any equivalent degree Knowledge, Skills and Abilities Effective command over verbal and written communication with good interpersonal skills. Command on Microsoft-Office (Word, Excel). Able to prioritize the tasks. Best in effective planning of work activities to meet the time lines. Experience Minimum 2 to 4 years of experience in GMP regulated pharmaceutical industry.

Department: Quality Control Location: Tehsil Inodra, Kangra (HP). Near by Pathankot Reporting to: QC Manager / Head Quality Department Key Responsibilities: Conduct routine testing of raw materials, in-process materials, and finished products as per approved specifications and standard test procedures (STPs). Perform chemical and instrumental analysis using HPLC, UV, IR, GC, KF, etc. Maintain accurate and up-to-date laboratory records, worksheets, and logbooks. Ensure timely calibration and maintenance of laboratory instruments and equipment. Review and follow Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). Assist in method development and method validation activities as required Conduct stability testing and prepare stability summary reports. Ensure compliance with company SOPs, quality standards, and regulatory requirements (such as USFDA, MHRA, WHO, etc.). Participate in internal and external audits and implement corrective and preventive actions (CAPA). Manage sampling, labeling, and storage of test samples as per SOPs. Handle out-of-specification (OOS), out-of-trend (OOT), and deviations according to quality procedures. Coordinate with production, QA, warehouse, and other departments for quality-related issues. Monitor environmental conditions of the lab as per the standard protocol. Desired Candidate Profile: Education: B.Pharm / M.Pharm / B.Sc / M.Sc Chemistry or related field Experience: 2–10 years in QC role within a pharmaceutical formulation plant Skills Required: Proficient in operating analytical instruments (HPLC, GC, etc.) Knowledge of GMP, GLP, ICH guidelines Strong documentation and communication skills Attention to detail and ability to work under pressure Good analytical and problem-solving skills

Role: Voice support Executive Qualification:+2 Pass/Graduate 15k-18k Experience: Fresher Language: Malayalam,Kannada,Telugu,Tamil Location: Shantinagar, Bengaluru Malayalam/Tamil+ English (or) Any 2 South Indian Language Preferred and Basic English

Qualification : M.Sc Microbiology / Biotechnology Experience : 7 to 10 year Location : Manjusar (Vadodara)

Roles and Responsibilities Conduct bioanalytical research activities such as method development, validation, and sample analysis using techniques like HPLC, GC, mass spectrometry, chromatography, spectrophotometry, and polarimeter. Develop and validate methods for bioanalysis of biologics and biosimilars according to regulatory requirements (e.g., USFDA). Collaborate with cross-functional teams to ensure timely delivery of high-quality results. Perform stability testing of biological products under various conditions. Troubleshoot issues related to instrument calibration, maintenance, and operation. Desired Candidate Profile Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Pharmacy (M.Pharma) from an accredited institution or M.Sc. Strong understanding of analytical instruments such as HPLC/UPLC/GC/MS/ICP-MS/Wet Analysis etc.

Developed personal care and cosmetics products from concept formulation to final production. Performed stability testing and troubleshooting of unstable formulas. Performed stability testing and troubleshooting of unstable formulas Required Candidate profile B.TEC/M. TEC in Cosmetic from leading Cosmetology College or B.Tec/M.Tec from ICT Mumbai Exp Should have 2-3Yrs of exp in leading Indian MNC/MNC/3rd Party Manufacturing, in Personal care Products

To perform analysis of finished Products and in-process samples. Proficiency in using analytical instruments such as UV/VISIBLE and IR, HPLC Handling of laboratory incidents and deviation. Extensive knowledge of GMP regulations in cGMP Manufacturing Environment. Chemical and Instrumental analysis of In process and finished products. To perform analysis of stability samples. To perform the calibration of instruments like HPLC, Dissolution tester, UV Spectrophotometer. Analysis of OOS/OOT

Knowledge of proper operation and cleaning of Machine & Area related to Granulation, Compression, Coating and Capsule Filling Knowledge of BMR/BPR preparation and SOP preparation Knowledge of Equipment and area qualification and validation activity

JOB DESCRIPTION Department : Quality Control Chemical Designation : Manager – Stability Reporting To : Head – Quality Control Educational Qualification : M. Pharma / M.Sc. (Chemistry/Pharmaceutical Sciences) Job Responsibilities 1.Responsible for preparation and review of Stability Study Protocols, Stability Study Reports, and Stability Summary Sheets for all products (General Injectables and OSD). 2 Responsible for initiation, monitoring, and timely execution of stability studies for registration batches, validation batches, and commercial batches as per ICH guidelines. 3 Responsible for managing stability chambers, their qualification, calibration, and monitoring as per regulatory and internal guidelines. 4 Responsible for monitoring pull-out schedules, analysis of stability samples, and ensuring timely reporting. 5 Responsible for statistical analysis, trending, and evaluation of stability data, including identification and investigation of Out of Trend (OOT) and Out of Specification (OOS) results. 6 Responsible for preparation, review, and approval of analytical reports for Finished Products, In-process materials, Raw Materials, Packaging Materials, Water and Steam (Condensate) samples, including stability samples. 7 Responsible for preparation, review, and execution of Analytical Method Transfers and Method Validations related to stability and routine testing. 8 Responsible for preparation and review of Standard Operating Procedures (SOPs), Analytical Test Data Sheets, General Test Procedures, Specifications, and Calibration Data Sheets. 9 Responsible for review and handling of laboratory incidents, Out of Calibration (OOC) reports, deviations, OOS, OOE, OOT events, Change Controls, and Corrective and Preventive Actions (CAPA). 10 Responsible for Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) implementation and compliance across the team. 11 Responsible for preparation/review of Qualification Reports/Protocols for instruments and equipment used in the QC Laboratory. 12 Responsible for preventive maintenance schedules, calibration schedules, and management of instruments, including handling of breakdowns. 13 Responsible for management of Working Standards, Reference Standards, and Impurity Standards, including procurement, qualification, issuance, and maintenance. 14 Responsible for allocation of work, supervision, and review of activities performed by the QC team members and ensuring section-wise coordination. 15 Responsible for providing GMP/SOP/Analytical training to QC personnel and ensuring compliance to safety practices within the QC department. 16 Responsible for acting as Section Head and taking charge in the absence of the QC Head to ensure continuity and compliance. 17 Responsible for executing and monitoring QC activities related to the General block and Oncology block (ADL, R&D) at BDR Pharmaceuticals International Pvt Ltd, Baska Site. 18 Responsible for self-training and tracking of training status for self and team members on all applicable SOPs and protocols. 19 Responsible for cross-functional communication with R&D, QA, Production, and Regulatory Affairs teams for new product stability requirements, troubleshooting, and regulatory submissions. 20 Additional responsibilities shall be assigned as per organizational requirements based on operational needs.

1- QC Exe-Chemical Testing Raw material Testing, finished product and stability testing 2. QMS Executive -CAPA, Deviations, Change Control 5 years Investigations, risk mgmt, documentation 3.QA Officer I year Support work, document control, audit prep Required Candidate profile 4.QA Exe —Training 3 years Conducting cGMP training, maintaining records 5. QA Exe—Validation 5 years (process, cleaning, equipment, HVAC) FDA Audit must Qualification:- M.Sc /B.Pharma/ M.Pharma