Deputy Manager-QA

Job Description

• Ensure all the computerized systems meeting the 21 CFR Part 11, EU ANNEX 11and GAMP5 guidelines requirements.
• Perform, review & approve computerized system validation life cycle deliverables.
• Responsible for implementation and compliance of data integrity at site as DICO (Data Integrity Compliance officer).
• Implement regimen of Data integrity checks on shopfloor and updating of Data Integrity Risk Assessment (DIRA).
• Responsible for handling and compliance of SOPs related to Data Integrity & IT systems.
• Review / conduct of investigations related to Data integrity, Computerized Systems, and engineering department as applicable.
• Coordination for data integrity and IT-systems projects with stakeholders at site and corporate as well.
• Handling & Participation in internal & Data Integrity audits, its compliance.
• Involve in selection of Data Integrity (DI) champions & Impart necessary trainings to the DI champions
• Review of Change controls, Deviations, CAPA and other QMS tools.
• Review of Periodic review reports.
• Participated in supplier assessment for Computerized Systems, instruments & equipment&aposs etc.
• Review approve the schedules of data back-up & restoration, time synchronization etc.
• Audit trail reports review of computerized systems i.e. HMI, SCADA, DCS, etc.
• Review and ensure the compliance of user management activities of Computerized Systems.
• Preparation / review of the quality risk assessments i.e. part 11 compliance, data integrity etc.
• Review the Qualification documents of the manufacturing equipment&aposs, facility, utilities and associated ancillary systems.
• CAPA effectiveness verification.
• GMP compliance verification for the manufacturing equipment area, utilities and testing instruments.
• Review of software application qualifications.
• Comply with SHE Guidelines, SHE Rules and Regulations. Comply with usage of PPE wherever applicable.
• Observe unsafe acts and conditions and take corrective & preventive actions immediately, as necessary.
• Report any incident / accident / near miss / illness to the superiors.
• Follow company&aposs quality procedures, standards, and specifications.
• And any other job as may be assigned to you from time to time by HOD.
• Also responsible for the work of the senior, in absence of senior.

Qualifications

Bachelors Degree

Required Skills

CSV

About Us

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.

About The Team

Piramal Critical Care (PCC), under Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, is the third largest producer of Inhaled Anaesthetics and a global player in hospital generics. Motivated by its vision to deliver critical care solutions for patients and healthcare providers across the globe, PCC is committed to enabling sustainable and profitable growth for all its stakeholders.

PCC maintains a wide presence across the USA, Europe and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anaesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management. PCC has wholly-owned, state-of-the-art manufacturing facilities in the US and India that have successfully cleared periodical inspections by the US FDA, UK MHRA and other regulators.

Its core strength lies in a highly qualified global workforce of more than 400 employees across 16 countries. PCC is focused on further expanding its global footprint through new product additions in the critical care space.

Committed to corporate social responsibility alongside Piramal Group, PCC collaborates with various partner organizations and proudly takes an active role in providing hope and resources to those in need, as well as caring for the environment.

Job Info

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Skills Required

Csv