AddressJob Overview
This is the second line to Department head to assist in handling Quality control Department . Accountable for Managing Stability section , Change control Management , Deviation and OOS investigations. Stability summary and Trend preparation.
Key Stakeholders: Internal
Operations, Marketing, Quality, R & D, Finance , BD and customers
Key Stakeholders: External
Vendors and Customers on need basis.
Reporting Structure
Role directly reports to Chief Manager – Quality Control
Experience
PhD/MSc in Analytical Chemistry, Pharmaceutical Chemistry or any related field.USFDA and EDQM Expereience is must
CompetenciesRoles and Responsibilities:
1. Planning and analysis of stability samples .
2. Change control , OOS and Deviation investigation through Trackwise
3. Stability summary and Trend preparation .
4. Stability chamber Management .
5. Inprocess/Finished product Sample analysis
6. Calibration and qualification of QC instrument
7. Hands on Experience on HPLC/GC/UV.
8. To maintain the documentation as per cGMP.
9. Audit and Compliance
10. To handle the responsibilities of reporting authority in his/her absence.
11. Lab Reagents/Chemicals/Consumables management to avoid delay in analysis.
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.
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.
