Senior Executive – Quality Control

Piramal Pharma Ltd; Dhar; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Piramal Pharma Solutions seeks a Senior Executive - Quality Control to perform analytical method validation, verification and transfer across multiple test areas (assay, dissolution, residual solvents, nitrosamines) with LC-MS/HPLC/GC/UV/IR/AAS instrumentation. Will ensure GLP/GMP compliance, maintain lab records, and support OOS investigations. Join a global CDMO with strong regulatory focus.

Qualifications

• Perform analytical method validation, verification and transfer per regulatory requirements.
• Handle tests like assay, dissolution, residual solvent, nitrosamines.
• Maintain GLP/GMP compliance in the lab.
• Prepare protocols and reports for validation/transfer projects.

Responsibilities

• Perform validation/verification/transfer activities on assays, dissolution and related tests.
• Prepare transfer/validation protocols and reports.
• Execute transfer/validation activities for new projects.
• Document deviations and incidents; report to Head QC.
• Maintain QC laboratory records and instrument usage logs.
• Operate ENSUR and TrackWise for OOS/OOT investigations.
• Prepare reagents and standard solutions as required.
• Analyze vendor/reference samples as part of QC processes.

Skills

Analytical method validation

Method verification

Method transfer

GLP/GMP compliance

Lab documentation

LC-MS

HPLC

GC

UV

IR

AAS

Tools

ENSUR

TrackWise

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 - Quality Control

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.

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