Senior Executive – Quality Control

Piramal Pharma Limited; Pithampur; On-site; INR 300,000 - 550,000; Full time

Job summary

Piramal Pharma Solutions in India is seeking a Senior Executive – Quality Control to perform analytical method validation, verification and transfer across assays such as assay, dissolution, residual solvent, nitrosamine impurities, and related tests using instruments including LC-MS, HPLC, GC, UV, IR and AAS.

You will maintain GLP/GMP compliance, prepare transfer protocols and reports, execute method transfer/validation activities for new projects, and ensure accurate documentation, corrective

Qualifications

• Experience in analytical method validation/verification/transfer.
• Proficiency with LC-MS, HPLC, GC, UV/Vis, IR and AAS.
• Familiarity with GLP/GMP and cGMP documentation.

Responsibilities

• Perform analytical method validation, verification and transfer across tests.
• Prepare validation/transfer protocols and reports.
• Execute method transfer/validation activities for new projects.
• Maintain lab records and ensure cGMP/GLP compliance.

Skills

Analytical method validation

Method verification

Method transfer

LC-MS

HPLC

GC

UV/Vis

IR

AAS

Documentation

Tools

ENSUR

TrackWise

Job description

Be the First to ApplyDivisionPiramal Pharma SolutionsPiramal 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.comJob TitleSenior Executive – Quality ControlJob DescriptionTo 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.