Manager – Quality eCompliance
Location: Mumbai, Maharashtra, India
Department: Quality eCompliance
Business Unit: Piramal Pharma Limited (PPL)
Travel Requirement: Low
Job Overview
Piramal Pharma Limited (PPL) is seeking an experienced Manager – Quality eCompliance to oversee Computer System Validation (CSV) and IT compliance activities at the site. The role is responsible for defining validation strategies, reviewing validation and QMS documentation, and ensuring all computerized systems maintain compliance throughout their lifecycle. The incumbent will support corporate quality initiatives, coordinate with vendors and project teams, participate in audits, and guide site teams on IT compliance and automation projects.
Key Responsibilities
Define validation strategy and review CSV deliverables for site IT projects (URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, Risk Assessment, etc.).
Author, review, and approve SOPs, guidelines, and policies related to computer system validations.
Support Corporate Quality eCompliance initiatives across Piramal sites.
Represent the site during regulatory and internal audits, ensuring compliance against audit findings.
Conduct periodic internal audits, assessments, and data integrity checks to maintain compliance of IT/OT systems.
Ensure compliance of CSV documentation across all phases of the software lifecycle (project, operational, and retirement).
Validate IT infrastructure, including networks, servers, cloud, and databases, in line with quality standards.
Review QMS documents such as change controls, deviations, and user access forms; approve root cause analysis and CAPAs.
Perform gap assessments per applicable regulatory guidelines and updates.
Coordinate with third-party vendors for timely completion of validation and qualification activities.
Participate in automation and harmonization projects initiated by corporate or site teams.
Provide guidance and mentoring to site teams on compliance for IT and electronic systems.
Attend QeC governance meetings and provide timely responses to corporate Quality eCompliance requirements.
Collaborate with CSV & Project Managers to ensure project timelines and deliverables are met.
Minimum Qualifications & Experience
Master’s or Bachelor’s degree in Chemistry, Life Sciences, IT, or a related field.
Minimum 5–7 years of experience in computer system validation, IT compliance, or quality assurance in a regulated pharmaceutical or biotechnology environment.
Strong understanding of regulatory guidelines (FDA, EMA, CDSCO) and GxP requirements.
Proven experience managing audits, risk assessments, and QMS document reviews.
Excellent analytical, organizational, and communication skills.
Ability to manage multiple projects and collaborate across functions.
Skills & Competencies
Leadership skills with ability to guide and mentor teams.
Strong stakeholder management capabilities.
Analytical and solution-oriented mindset with a focus on compliance and process improvement.
Clear communication and documentation skills.
Proactive approach to identifying risks, gaps, and implementing mitigation strategies.
About Piramal Pharma Limited (PPL)
Piramal Pharma Limited (PPL) is a global pharmaceutical and CDMO leader, providing end-to-end solutions across the drug lifecycle. With a presence in North America, Europe, and Asia, PPL offers services including drug discovery, process and pharmaceutical development, clinical trial supplies, and commercial manufacturing of APIs and finished dosage forms. The company specializes in advanced technologies such as peptide products, highly potent APIs, antibody-drug conjugates, sterile fill/finish, and biologics including vaccines, gene therapies, and monoclonal antibodies.
Equal Employment Opportunity
Piramal Group is committed to providing equal employment opportunities to all employees and applicants without regard to legally protected characteristics. Employment decisions are based on qualifications, skills, performance, and achievements, ensuring fair treatment in recruitment, placement, promotion, compensation, and working conditions.
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