Piramal Pharma

CDMO and hospital generics, consumer health

Senior Executive-Quality Control

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timePithampur Industrial Area, Pithampur, Madhya Pradesh, IndiaNo salary listedIn-person

About the Job

Requirements

Skill in handling LC-MS, HPLC, GC, UV, IR, AAS, and Malvern instruments.
Knowledge of regulatory documentation and GLP and GMP requirements.

Responsibilities

Perform analytical method validation, method verification, and method transfer activities for tests including assay, dissolution, related substances, residual solvents, and nitrosamine impurities.
Analyze finished products, in-process samples, hold-time samples, raw materials, and stability samples, with related documentation in accordance with cGMP.
Prepare analytical method transfer, validation, and verification protocols and reports.
Execute analytical method transfer, validation, and verification activities for new projects.
Report deviations, incidents, out-of-trend results, or out-of-specification results promptly to the Section Head or Head of QC.
Implement GLP and GMP requirements.
Control and maintain QC laboratory records, including laboratory notebooks, chromatograms, and certificates of analysis.
Operate ENSUR and TrackWise, and carry out out-of-specification, out-of-trend, and laboratory investigation reports.
Prepare and standardize volumetric solutions, reagents, and indicator solutions as required.
Document analytical records concurrently, store raw data, and make online entries in instrument and equipment usage logbooks.
Analyze vendor approval samples or reference listed drug samples.

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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

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.

About the Company

Piramal Pharma

CDMO and hospital generics, consumer health

Piramal Pharma is a diversified pharmaceutical group with three divisions: Piramal Pharma Solutions (PPS), Piramal Critical Care (PCC), and the Consumer Products Division (CPD). PPS operates as a contract development and manufacturing organization, providing development and manufacturing services across the drug lifecycle for clients in North America, Europe, and Asia through a globally connected network. PCC specializes in complex hospital generics, particularly inhaled anesthetics, serving markets in the USA, Europe, and over 100 countries. CPD leads consumer healthcare in India with brands such as Littles, Lacto Calamine, i-pill, Tetmosol, Polycrol, and Tri Activ, and the company serves pharmaceutical companies, hospitals, and consumers by leveraging its manufacturing scale and distribution network.

Company size: 1,001-5,000
Company stage: IPO
Headquarters: Maharashtra, India
Founded: 2020

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