Research Associate- Analytical

Piramal Pharma Ltd; Navi Mumbai; Sur place; INR 350 000 - 550 000; Plein temps

Résumé du poste

Piramal Critical Care (PCC), a unit of Piramal Pharma, invites applications for Research Associate- Analytical in Navi Mumbai. You will support R&D Analytical Development to complete projects on time, assist in lab management, and contribute to lab competency building.

Responsibilities include analytical method development/validation (API/formulation), method transfer, data interpretation, and ensuring cGMP and QMS compliance. A MSc in Chemistry with 0–4 years' experience is preferred.

Qualifications

• M.Sc. in Chemistry or related functionary.
• 0-4 years of experience.
• Knowledge of QMS, ICH guidelines, and cGMP.
• Strong data interpretation and technical writing.

Responsabilités

• Perform analytical method development and validation for API and Formulation products, raw materials, excipients.
• Support analytical method transfer to manufacturing site and troubleshoot on-line.
• Support routine analysis; generate, interpret and review experimental data.
• Coordinate with QA, Regulatory and other interfaces for method transfer and tech transfer.

Connaissances

Analytical development

HPLC

GC

Data interpretation

Formation

M.S.C. in Chemistry

Outils

MS Office

Description du poste

Piramal Critical Care (PCC), a business unit of Piramal Pharma, is the fourth-largest producer of inhaled anesthetics and a global player in hospital generics. We are motivated by our vision of commitment to delivering critical care solutions for patients and healthcare providers across the globe while achieving sustainable and profitable growth for all the stakeholders.

PCC maintains a wide presence across the US, Europe, and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management.

PCC has a strong manufacturing and process development experience with wholly-owned, state-of-the-art manufacturing facilities in the United States and India, inspected periodically by the US FDA and the UK MHRA and other regulators. The strategic locations of our facilities help us supply high-quality products around the world, timely at optimal costs.

For more details, please visit https://www.piramalcriticalcare.com/global/

Job Title

Research Associate- Analytical

Job Description

Support R&D Analytical Development to complete projects with high quality within time frame; Support Manager in Lab and EHS management; Support Manager in Lab competency building;

Area of Responsibility

Analytical development for new or identified product
(API/formulation/Speciality chemicals)

• Under general supervision of lab team leader or R & D Manager, independently perform routine scientific research tasks using standard techniques, procedures and equipment.
• Execute experimental plans, support in investigate technical concepts & needs,
• Perform Analytical Method development and validation under supervision of reporting manager for API and Formulation products, raw materials, excipients using analytical techniques such as HPLC, GC, etc. literature search.
• Support in performing Analytical method transfer for Formulation project at manufacturing site. On-line troubleshooting as well as during method development & method transfer.
• Support routine analysis. Experimental data generation, interpretation and review for API & formulation analytical development.
• Interface with organizational departments in analytical method transfer of new products technology
• propose experimental program and discuss with manager/R&D engineers
• Show analytical chemistry proficiency and use advanced analytical techniques to develop analytical testing methods for new product.

Business support

• Providing timely support to plant / Regulatory or QA in resolving analytical related queries,
• Analyse and support in resolving research issues in a timely and accurate manner.

Compliance and admin

• Analysis of development batches and routine stability samples.
• Preparation of standard test procedure, SOP,IOP
• Follow cGMP compliance practices in the lab.
• Coordination with all interfaces for the support in successful product development.
• Responsible for maintenance of assigned laboratory section and lab work as per CGLP requirement.
• Perform general lab assignments e.g. analytical reagents and columns inventory management, Calibration of analytical instruments, Maintaining IQ/ OQ/ PQ documentation for analytical instruments, lab house-keeping, Implementation of SOP in R&D Lab, Updating/ Renewal of Annual Maintenance Contract for analytical instrument, as assigned.

People management

• Cordinate with team members on assigned tasks and EHS issues

Tech transfer

• Provide onsite or offsite support for execution of transfer activity as per Plan
• Support in preparation,for Analytical method transfer documents such as Method assessment document, Analytical method transfer plan, Protocol and Reports, stability data etc.

Education Qualification

• M.Sc. ( Chemistry or its related functionary)

Minimum Experience (in Years)

• 0-4 years

Key Competency

• Technical & Professional Knowledge
• Knowledge QMS, ICH guideline,& cGMP
• Ability to interpret data, draw conclusions, and present results.
• Technical writing skills. MS Office (Word, Excel & PowerPoint) and Internet Applications.