Senior Executive - Quality Assurance

Piramal Pharma Limited; Navi Mumbai; On-site; INR 600,000 - 900,000; Full time

Job summary

Piramal Pharma Limited in Navi Mumbai seeks a Senior Executive - Quality Assurance to oversee QC and manufacturing quality, review analytical data and batch records, ensure adherence to cGMP and data integrity, and support QMS elements such as deviations, CAPAs, and OOS/OOT investigations.

You will participate in cleaning validation, line clearance, APR preparation, and regulatory inspections, coordinating with production, quality control, and external auditors to maintain compliant operations

Qualifications

• Experience in quality oversight of QC and manufacturing activities.
• Review of analytical data, batch records, and QMS elements.
• Knowledge of cGMP, data integrity and regulatory requirements.

Responsibilities

• Oversee QC and manufacturing quality oversight through data review and batch records.
• Review QC data, electronic and manual records, audit trails for data integrity.
• Review specifications, procedures, lab SOPs and instrument calibration status.
• Manage Batch Release activities and preparation/review of APRs.
• Initiate and review QMS elements: Deviations, Change Controls, OOS, OOT, CAPA.
• Support during regulatory inspections and customer audits.

Skills

Quality Assurance

QC Review

Data Integrity

Regulatory Compliance

Audit Support

Job description

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients 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 like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide. For more details, please visit : www.piramalpharmasolutions.com

Senior Executive - Quality Assurance

Job Description

• Responsible for ensuring quality oversight and compliance of QC and manufacturing activities through comprehensive review of analytical data, batch records, and QMS elements.
• The role involves batch release activities, review of QC data, including electronic and documented/manual records, audit trails and ensuring adherence to cGMP, data integrity, and regulatory requirements.
• The incumbent will also support cleaning validation, line clearance, dispatch activities, and preparation and review of Annual Product Reviews (APR) to ensure consistent product quality and regulatory compliance.
• Review and evaluation of QC analytical data, including thorough electronic data and audit trail review to ensure data integrity.
• Review of analytical specifications, STPs/analytical procedures, protocols, and laboratory-related SOPs.
• Review of QC laboratory qualification/calibration status of analytical instruments.
• Batch Release Management.
• Hands on analytical experience.
• Review of batch manufacturing and packaging records, including audit trail verification.
• Preparation and Review of APR.
• Oversight and review of QC laboratory activities to ensure adherence to SOPs and quality standards.
• Initiation, investigation, and review of QMS elements such as Deviations, Change Controls, OOS, OOT, and CAPA.
• Review and execution of cleaning validation activities in accordance with regulatory guidelines.
• Support during regulatory inspections and customer audits.

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the-counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October2020, PPL received a 20% strategic growth investment from the Carlyle Group.

PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.