Executive - Quality Assurance

Preparation and updation of Validation Master Plan (VMP)
- Preparation of Process validation, Computer system validation protocol and report.
- Preparation of product matrix and Cleaning Validation/verification protocol and Report.
- Preparation of qualification and requalification protocol and report for processing equipment/instrument, utilities, and facility.
- Preparation of area validation protocol and reports.
- Preparation and review of quality risk assessments.
- Review of calibration certificate (External/internal).
- Handling of Change control, deviation, incident.
- Statistical Process Monitoring.
- Audit compliance coordination, to compile CAPA and prepare response to Audit report in co-ordination with QA Head and technical team.
- Execution of requirements for food / Dietary supplements regulations for export market (US)-21 CFR Part 111
- Area and line clearance for Manufacturing, Packing & Dispensing activity in production area.
- In process checks in Manufacturing and Packing activity.
- Inspection of dispensing activity intermediately.
- Daily verification of weighing balance calibration activity.
- Daily verification of environmental monitoring of raw material staging area and Manufacturing and Packing area.
- Verification of each equipment cleanliness and area cleanliness during line clearance
- Verification and review of online Batch Manufacturing Records.
- Sampling of bulk stage and finished goods analysis and control sample.
- Verification of production documents.
- Daily non conformance observation reported and maintained.
- In process quality checks in Tablet, Liquid, HNH, ANH manufacturing dept.
- Line Clearance for Manufacturing, Packing & Dispensing activity.
- Sampling of Bulk and Finished goods
- Review of production records and Finished Goods verification
- On job training to the new people working in the production area.
- Online observation of process deviation and effective implementation of CAPA.
- Reporting of daily non conformance.
- Ensuring avoidance of breach of data integrity in area.
- Implementation of effective sanitation program in area.
- Imparting required training to shop floor personnel.
- Adherence to the requirements of EHS norms.
- Execution of various initiatives as are suggested by corporate functions (SEEDS, Learning university, Quality mindset).
- Customer centricity.
- Document Archival.

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.