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Division
Piramal Pharma Solutions
Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.
This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.
Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
For more details, please visit : www.piramalpharmasolutions.com
Job Title
QC Analyst II - Stability
Job Description
The QC Analyst II - Stability is responsible for performing analytical testing of stability samples in support of the site's Stability Program. This role executes stability studies, performs chromatographic and compendial testing, reviews analytical data, monitors study timelines, and ensures compliance with cGMP requirements, ICH guidelines, approved protocols, and regulatory commitments. The analyst collaborates closely with Quality Control, Quality Assurance, Regulatory Affairs, and Manufacturing to maintain an effective and compliant stability program.
Key responsibilities
- Perform analytical testing of stability samples using HPLC, UPLC, GC, dissolution, UV-Vis, FTIR, and other compendial methods.
- Execute stability studies in accordance with approved protocols, product commitments, and internal procedures.
- Prepare samples, standards, diluents, mobile phases, and reagents required for stability testing.
- Operate, calibrate, troubleshoot, and perform routine maintenance on analytical instrumentation.
- Process, integrate, review, and interpret analytical data using Empower or equivalent chromatography software.
- Review chromatograms for peak integrity, retention time consistency, system suitability, and compliance with specifications.
- Support stability sample inventory management, pull schedules, storage conditions, and testing timelines.
- Trend and evaluate stability data to identify potential quality concerns, OOT results, and product performance trends.
- Document all analytical activities in laboratory notebooks, LIMS, and controlled records in accordance with GDP requirements.
- Participate in laboratory investigations related to OOS, OOT, atypical results, and stability-related deviations.
- Support method transfers, method verifications, and method validation activities as required.
- Assist with preparation and review of stability protocols, reports, and supporting documentation.
- Support regulatory inspections, customer audits, and internal audits related to stability activities.
- Maintain laboratory readiness through proper documentation, instrument logbooks, reagent control, and compliance with safety requirements.
- Collaborate with QA, Manufacturing, Regulatory Affairs, Stability Program Management, and other departments to support business priorities.
Education/Experience
The successful candidate must meet one of the following education/experience combinations:
- Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, Microbiology, or related scientific discipline.
- Minimum 2-4 years of pharmaceutical Quality Control laboratory experience in a cGMP-regulated environment.
- Experience performing analytical testing using HPLC, UPLC, and/or GC instrumentation.
- Experience supporting stability studies and stability testing preferred.
- Experience with dissolution, FTIR, Karl Fischer Moisture, UV-Vis, pH, conductivity, and wet chemistry testing preferred.
- Experience using laboratory systems such as Empower, LIMS, or equivalent data management systems preferred.
Job Competencies
- Working knowledge of pharmaceutical stability programs and ICH stability guidelines.
- Strong understanding of cGMP requirements, Good Documentation Practices (GDP), and Data Integrity principles.
- Knowledge of USP, EP, and compendial testing requirements.
- Proficiency with HPLC, UPLC, GC, dissolution, UV-Vis, FTIR, Karl Fischer, and associated laboratory techniques.
- Ability to review, interpret, and trend analytical and stability data.
- Experience investigating OOS, OOT, and atypical laboratory results.
- Strong organizational skills with the ability to manage multiple studies and testing timelines simultaneously.
- Ability to work independently with minimal supervision while maintaining a high degree of accuracy.
- Strong written and verbal communication skills.
- Proficiency with Microsoft Office applications including Excel, Word, and PowerPoint.
Job Conditions
The physical demands and work environment described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. If accommodations are needed, requests should be made to the Human Resources Department.
Physical Demands
- Frequent standing, walking, bending, reaching, and lifting may be required.
- Ability to lift and carry laboratory materials, reagents, and sample containers up to 25 pounds.
- Extended periods of sitting, computer use, data review, and documentation activities are required.
- Frequent use of laboratory instruments, analytical equipment, and computerized systems.
- Ability to perform repetitive tasks requiring attention to detail and manual dexterity.
Work Environment
- Work is performed primarily in a Quality Control laboratory supporting pharmaceutical manufacturing operations.
- Regular exposure to laboratory equipment including HPLC, UPLC, GC, dissolution systems, balances, and other analytical instrumentation.
- Responsibilities may include working within stability sample storage areas and environmental chambers.
- Potential limited exposure to laboratory chemicals, solvents, and pharmaceutical materials.
- Personal protective equipment (PPE), including safety glasses, laboratory coats, gloves, and appropriate footwear, is required as designated by site procedures.
- Compliance with cGMP requirements, data integrity principles, laboratory safety procedures, and applicable regulatory requirements is expected at all times.
- Occasional support may be required during investigations, audits, stability study deadlines, or business-critical testing activities.
