Sr.Executive QC

Piramal Pharma Ltd; Dahej; On-site; INR 450,000 - 650,000; Full time

Job summary

Piramal Critical Care in Gujarat seeks a Sr. Executive QC to perform in-process, raw material, and stability testing with advanced analytics. The role requires BSc/MSc in Chemistry and 4–6 years of relevant experience, strong instrument calibration skills, and adherence to GLP and 21 CFR Part 11.

Expect rigorous documentation, method development, and timely reporting. Responsibilities include maintaining calibration records, preparing SOPs, and ensuring compliance in a fast-paced QC lab

Qualifications

• BSC / MSC Chemistry with 4 to 6 Yrs Experience.
• Strong analytical method knowledge and GLP awareness.
• Experience with instrument calibration and documentation.

Responsibilities

• Analysis of in-process, intermediates, raw materials, packaging materials and stability samples as per STP.
• Calibrate QC instruments and maintain calibration records and log books.
• Perform analytical method validation and development as required.
• Prepare and update QC SOPs/STPs and ensure 21 CFR Part 11 compliance.
• Report OOS/incidence/deviation timely to the lab supervisor.
• Ensure timely release of samples and maintain sampling schedules.

Tools

HPLC

GC

UV

IR

ParticleSizer

KF titrator

Job description

Piramal Critical Care

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

Sr.Executive QC

Job Description

BSC / MSC Chemistry with 4 to 6 Yrs Experience

• Analysis of in process, intermediate, raw material, packaging material, ETP and utility samples, stability samples, R&D samples and other samples as per plant requirement as per defined STP’s.
• Well versed with advance analytical instrument like HPLC, GC, UV, IR, particle sizer, KF titrator.
• Calibration of all equipment in QC department as per SOP’s.
• To maintain the records of calibration, working standards, stability data, AMC, outside calibration records, instrument log book, validation report, in process and intermediates test reports as per GLP.
• To perform analytical method validation as and when required.
• To perform analytical method development project as and when required.
• To prepare and update the SOP’s and STP’s of QC department.
• To maintain 21 CFR part 11 compliance in the laboratory.
• To release the in process, intermediates samples within defined time line.
• To perform the sampling of raw materials, packaging materials as per sampling plan.
• To report any abnormality in analysis and timely reporting of OOS, incidence, disregard and deviation to the lab supervisor.
• To maintain calibration inside and outside, AMC and stability samples withdrawal schedule.
• To follow the instruction of lab supervisor for any specific task.