Executive - Dqa

Oversee and support the overall activities during the product development life cycle from Quality perspective in R&D (API and intermediates)
- To understand the site needs with respect to system establishment and sustainability.
- Author / Review and approve the SOPs/work directions required for implementing the Quality Systems in R&D activities as per GLP and regulatory requirements. Ensure effective implementation of SOPs/ work directions.
- Review and approve Lab Familiarization Reports (LFR), Product Development Reports (PDR, Technology transfer, Product Specification & STPs, Analytical method validation, method transfer, qualification, calibration, process validation protocol and reports. Ensure effective execution of these activities.
- Periodic audits of R&D laboratory. Ensure online documentation and review lab notebooks, PDR/LFR documents, analytical documents and stability data.
- Effective maintenance of R&D records, distribution and archival systems
- Perform cGMP audit of R&D facilities and operations. Assist the team in auditing contract manufacturers / vendors / contract testing laboratory.
- Ensure R&D team is trained for their relevant job function and GMP / GLP training
- Provide quality related inputs to new projects, existing project, up gradations etc.
- Participate in identification of Key Starting Material (KSM) / Registered Starting Material (RSM) and ensure that it is correctly identified.
- Participate in handling of OOS, OOT, Deviations, Batch failures, Investigations and CAPA implementation at site.
- Establish raw material standards by studying manufacturing / R&D requirements -conferring with suppliers
- Responsible to follow the safety and environmental procedures deployed in the site

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.