Senior Executive-QC

Piramal Critical Care, Inc.; India; On-site; INR 600,000 - 800,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Senior Executive-QC to perform analytical method validation, verification, and transfer across multiple tests using LC-MS/HPLC/GC/UV/IR/AAS. The role emphasizes strict adherence to GLP/GMP and meticulous documentation of results and deviations.

The candidate will handle finished products, in-process, raw materials, and stability samples, prepare transfer/validation protocols, and ensure proper data management in ENSUR and TrackWise.

Qualifications

• Perform analytical method validation, verification and transfer activities for various tests.
• Analyze finished products, in-process samples, raw materials and stability samples per cGMP.
• Prepare and execute validation/ transfer protocols and reports.
• Carry out analytics for new projects with proper documentation.
• Report deviations (OOT/OOS) promptly to the Section Head/Head QC.
• Implement GLP/GMP requirements and maintain lab records.
• Operate in ENSUR and TrackWise systems for data management and investigations.
• Prepare standards, reagents and solutions as needed.

Responsibilities

• Perform Analytical method validation/method verification/Method transfer activities on different tests like Assay/Dissolution/RS/Residual solvent/Nitrosamine impurities/dissolution with instruments like LC-MS/HPLC/GC/UV/IR/AAS/Malvern and maintain regulatory documentation.
• Ensure compliance with GLP/GMP in the lab and maintain laboratory records and COA storage.
• Prepare validation/transfer protocols and reports and execute validation/transfer activities for new projects.
• Report any deviation, incident, OOS or OOT to the section head promptly.
• Carry out remediation and lab investigations as required under ENSUR and TrackWise.
• Maintain instrument usage logs and ensure proper storage of data and raw results.
• Analyze vendor approval samples or reference standards as part of QA processes.
• Perform procedural documentation and standardization of solutions and reagents as needed.

Skills

Analytical validation

Method verification

Method transfer

Data documentation

Deviation reporting

GLP/GMP compliance

Tools

ENSUR

TrackWise

Job description

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

Job Description

To perform Analytical method validation/method verification/Method transfer activities on different tests like Assay/Dissolution/RS/Residual solvent/Nitrosamine impurities/ dissolution with skill of handling various instruments like LC-MS/HPLC/GC/ UV/IR/AAS/Malven etc and documentation as per Regulatory requirement and maintaining GLP / GMP requirements in lab.

• 1. Analysis of Finished products, In-process, Hold time, Raw Materials, stability samples and related documentation as per cGMP.
• 2. Preparation of the Analytical Method transfer/Validation/Verification protocol and reports.
• 3. Execution of Analytical Method transfer/Validation/Verification activity for new Projects.
• 4. Instant reporting in case of any deviation, incident, OOT or OOS to Section Head/ Head QC.
• 5. Any additional responsibility assigned by section head.
• 6. Implementation of GLP / GMP requirements.
• 7.To control and maintain QC Laboratory Records. (Like Laboratory notebook, Chromatograms, and COA etc.).
• 8.Operations with ENSUR and Track wise. (Carry out OOS, OOT, Lab Investigation report.)
• 9.Preparation and Standardization of volumetric solutions/ Reagents/ Indicator solution preparation as and when required.
• 10. Concurrent documentation of analytical records and storage of raw data, online entries in Instrument/ Equipment's usage logbooks.
• 11. Analysis of Vendor Approval samples or RLD Samples.