Executive - Quality Assurance

7 months ago

Telangana, India Piramal Enterprises Full time

Responsible for reviewing of Analytical Method Validation and Method Verification protocol and report for R&D and QC.
- Responsible for initiate, log-in, evaluation and closure for change control, Deviation and CAPA in Track Wise system.
- Responsible for review of OOS/LIR/Deviation/OOT investigation report.
- Responsible for tracking of document issuing/implementation.
- Ensure the compliance with respect to end to end QC activities.
- Responsible for tracking of QMS activity.
- Responsible for attending the customer call and answer the questions to the customer scientifically.
- Responsible for the GMP monitoring at site.
- Interact with internal customer for day to day activity and its compliance.
- Involve in the external (clients and regulatory) and internal audits and visits and to provide the support to address the queries.
- Filled the Customer questionnaires and send the documents on time frame.
- Responsible for timely response on client query.
- Responsible for provide the data for regulatory submission and drug license.
- Ensure, the documents archive as per the SOP for future reference. Follow the Quality agreements of customer.
- Preparation/review of PPQ protocol and report.
- Comply with SHE Guidelines, SHE Rules and Regulations.
- Implement emergency control plan.
- Maintain all relevant records under OHSAS & EMS Systems.
- Ensure compliance to Hazardous waste and chemical management.
- Report and investigate any incident/accident/ near miss/ illness to the superiors.

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.

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