Senior Executive-QC

Piramal Pharma Limited; India; On-site; INR 450,000 - 700,000; Full time

Job summary

Piramal Pharma Solutions in India is seeking a Senior Executive-QC responsible for analysis of stability and finish product samples, ensuring compliance with cGMP and GLP across Finished products, Raw Materials and related documentation.

The role involves handling QC samples receipt, standardization of reagents, maintaining lab records, reporting deviations, and supporting data integrity initiatives at the site.

Qualifications

• Experience with finished products, raw materials analysis per cGMP.
• Strong documentation and record-keeping skills.
• Familiarity with GLP/GMP requirements and data integrity.

Responsibilities

• Analysis of stability and finish product samples per cGMP.
• Receipt/inward/storage of QC samples and disposition after analysis.
• Prepare and standardize volumetric solutions/reagents/indicator solutions as needed.
• Maintain concurrent documentation of analytical records and data storage.
• Report deviations, OOT or OOS to Section Head promptly.
• Procure chemicals, reagents, standards for new projects as required.
• Allocate tasks and train workmen; maintain QC laboratory records.
• Ensure GLP/GMP compliance and support Data Integrity actions.

Skills

Stability analysis

QC laboratory procedures

Documentation

cGMP compliance

Data integrity awareness

Tools

GC

Dissolution

UV

Job description

Be the First to Apply 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 Senior Executive-QC

Analysis of Stability and Finish product samples.

• 1. Analysis of Finished products, Raw Materials, stability and related documentation as per cGMP.
• 2. Receipt/Inward/Storage of QC samples and Disposition of sample after analysis.
• 3. Preparation and Standardization of volumetric solutions/ Reagents/ Indicator solution preparation as and when required.
• 4. Concurrent documentation of analytical records and storage of raw data, Online entries in Instrument/ Equipments usage log books.
• 5. Instant reporting in case of any deviation, incident, OOT or OOS to Section Head/ Head QC.
• 6. Requirement / Procurement of chemical/ reagents/ standards/ columns required for new project.
• 7. Any additional responsibility assigned by section head.
• 8. Maintenance of Bin Card of chemical store.
• 9. Implementation of GLP / GMP requirements.
• 10 Allocate works to workmen and trained them.
• 11. To control and maintain QC Laboratory Records. (Like Laboratory note Book, Chromatograms, and COA etc.).
• 12. Analysis of Vendor Approval samples.
• 13. Review of laboratory chemicals.
• 14. Responsible for only run the method in the GC, Dissolution & UV does not access to Change the method, report format, cancellation of any run, or system and method configuration.
• 15. Support to site DICO (Data Integrity Compliance Officer) for monitoring and implementation of actions related to Data Integrity awareness at site.

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.

PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.