Job Description
Job Description
Job Overview
To ensure quality control testing of raw materials, intermediates, finished products, and stability samples as per regulatory and company standards.
Roles And Responsibilities
- Perform routine and non-routine analysis of raw materials, in-process, finished products, and stability samples.
- Conduct analysis using instruments like HPLC, GC, UV, FTIR, and other laboratory techniques.
- Prepare and review analytical reports, specifications, and SOPs.
- Ensure compliance with cGMP, GLP, and regulatory guidelines.
- Perform calibration and maintenance of laboratory instruments as per schedule.
- Conduct OOS (Out of Specification) and OOT (Out of Trend) investigations and document findings.
- Support analytical method validation and transfer activities.
- Maintain laboratory records, logbooks, and ensure proper documentation practices.
- Coordinate with cross-functional teams for quality-related activities.
- Handle deviations, change controls, and CAPAs as per regulatory requirements.
- Participate in internal and external audits and regulatory inspections.
Competencies
- Hands-on experience in handling analytical instruments like HPLC, GC, UV, and FTIR.
- Knowledge of cGMP, GLP, ICH, and regulatory guidelines (USFDA, MHRA, EU, etc.).
- Good documentation
- Strong analytical and problem-solving skills.
- Ability to work in a team and independently.
Experience
2 to 4 Yrs experience in Quality Control
Qualifications
MSc Chemistry
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 Info
- Job Identification 7760
- Job Category Quality Control
- Posting Date 03/01/2025, 01:39 PM
- Degree Level Master’s Degree
- Job Schedule Full time
- Locations Piramal, Thane, Maharashtra, 400703, IN