Senior Executive - QC

Piramal Pharma Limited; Dahej; On-site; INR 600,000 - 800,000; Full time

Job summary

Piramal Pharma Limited, a leader in hospital generics and critical care solutions, seeks a Senior Executive - QC in its India operations. The role focuses on in-process and finished material analysis, calibration, and adherence to GLP and 21 CFR Part 11.

The candidate should have 6–8 years of QC experience and a chemistry background. The position offers growth within a global manufacturing network and requires strong analytical skills, documentation discipline, and collaboration with the QC team

Qualifications

• MSc/ BSc Chemistry with 6–8 years of experience in QC and related areas.
• Familiarity with GLP and 21 CFR Part 11 compliance.
• Analytical method validation and development experience when required.

Responsibilities

• Analyze in-process, intermediate, raw material, packaging material, and stability samples as per STP.
• Calibrate QC equipment and maintain calibration records and instrument logs.
• Maintain GLP records, validation reports, and SOPs for QC department.
• Perform analytical method validation and support method development as needed.
• Prepare and update QC STPs and ensure timely reporting of OOS and deviations.

Education

MSc/ BSc Chemistry

Job description

Be the First to Apply Division 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 Senior Executive - QC Job Description Msc/ Bsc Chemistry Having 6 to 8 years experience and CTC will be 6 to 8 lac/ annum

Job Responsibility Band-1 (QC Sr-Executive )

• 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.
• 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.

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products. In addition, one of PPL's associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group. PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.