Senior Executive-QC
Piramal Pharma Ltd
Date: 2 weeks ago
City: Navi Mumbai, Maharashtra
Contract type: Full time
Job Overview
JOB DESCRIPTION
To lead and execute analytical method validation, transfer, and verification activities in compliance with regulatory and cGMP standards, ensuring robust analytical support for product development, regulatory submissions, and commercial manufacturing.
Competencies
4 -5 years in QC-AMV in a regulated pharmaceutical environment
Qualifications
M.Sc. (Chemistry/Analytical Chemistry) / M.Pharm
About Us
In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.
Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
Equal employment opportunity
Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.
We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.
About The Team
Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers 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 such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.
JOB DESCRIPTION
To lead and execute analytical method validation, transfer, and verification activities in compliance with regulatory and cGMP standards, ensuring robust analytical support for product development, regulatory submissions, and commercial manufacturing.
Competencies
- Plan, perform, and document Analytical Method Validation (AMV) and Analytical Method Transfer (AMT) for raw materials, intermediates, and finished drug products.
- Prepare and review protocols and reports related to method validation/verification/transfer in alignment with ICH Q2(R1) guidelines.
- Coordinate with R&D, AR&D, QA, RA, and manufacturing units for method transfer and troubleshooting activities.
- Perform routine and non-routine analysis using HPLC, UPLC, GC, UV, IR, dissolution apparatus, and other analytical instruments.
- Ensure timely qualification/calibration of instruments used in AMV lab.
- Review analytical documents like raw data, chromatograms, validation reports, SOPs, etc.
- Support regulatory inspections (USFDA, EU, ANVISA, WHO, etc.) and respond to queries related to AMV/AMT.
- Investigate OOS/OOT/Deviation/Incident related to AMV activities and provide effective CAPA.
- Maintain GLP and cGMP compliance across AMV operations.
4 -5 years in QC-AMV in a regulated pharmaceutical environment
Qualifications
M.Sc. (Chemistry/Analytical Chemistry) / M.Pharm
About Us
In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.
Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
Equal employment opportunity
Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.
We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.
About The Team
Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers 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 such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.
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