Job Description

JOB OVERVIEW:

Responsible for reviewing and approving Computer system validation (CSV) deliverables, user access management requests for centralized GxP applications (e.g., Ensur, TrackWise, Thycotic, etc.,) as a central QA, ensuring compliance with onboarding and offboarding processes, and maintaining training records. The role also includes conducting periodic review, audit trails as per defined schedules , maintenance of active user lists and maintaining system inventory. Supports QMS documentation, Data Integrity practices, and IT compliance activities to ensure readiness for audits and adherence to regulatory requirements.

KEY STAKEHOLDERS: INTERNAL

o Business - Site / Central Partner functions
o IT Team (e.g. SAP/ Infra / Quality IT / Allied / SAP Basis)

KEY STAKEHOLDERS: EXTERNAL

o IT Vendors
o IT Contractors/Consultants

REPORTING STRUCTURE:

o Reporting to Associate General Manager - QeC/CSV

QUALIFICATION:

o Graduate in Science/Pharmacy/Engineering
o Post Graduation - Science/MBA (Desirable)

EXPERIENCE:

o 4 to 6 years of experience in Quality Compliance, IT Quality Assurance, or Computer System Validation (CSV) within a regulated environment (e.g., pharmaceutical, biotech, or healthcare industry).
o Work experience in both IT Sector and Pharma Sector will be desirable.

SKILLS AND COMPETENCIES

o Strong understanding of User Access Management (UAM) processes
o Hands-on experience with GxP computerized systems (e.g., Ensur, TrackWise, Thycotic)
o Proficiency in audit trail review and periodic user access review
o Knowledge of 21 CFR Part 11, EU Annex 11, and Data Integrity (ALCOA+)
o Familiarity with QMS tools and processes (Deviation, CAPA, Change Control)
o Exposure to Computer System Validation (CSV) documentation and lifecycle
KEY ROLES & RESPONSIBILITIES:
To initiate/ review/ approve user access management forms of centralized applications such as Ensur, TrackWise, Thycotic etc.


To approve on-boarding/off-boarding , assignment of training to consultants/IT employees.


To perform periodic review and audit trail review of Central GxP computerized systems as per defined frequency.


To perform review and approval of validation deliverables of Central GxP applications and provide support to Central and Site IT teams in CSV and other IT compliance activities.


To perform the periodic review of active user list and maintaining of active user list of Central GxP applications.


To perform Review and approval of QMS documents e.g., Change control, Deviation, Incidents, CAPA, Extension, etc. as applicable for systems E.g., changes on Non GxP infra end user support, Readsoft and MSB Docs etc.


To support the internal QeC team in conducting Data Integrity training workshops. To ensure training for self on Data integrity processes and ensure that Data integrity as per ALCOA+ requirements are met performing activities.
To prepare the weekly report for presenting the status of QMS records (e.g., Change Control/ Deviation/ CAPA) and SOP nearing due date and share the status report with IT team leaders.
To provide support during regulatory/ Central Quality/ internal audits.


To inform DI Champion/PPL Manager in case of data integrity breach/issue.


Any other tasks as assigned by the reporting manager.



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 Limited (PPL) offers a portfolio of differentiated products and services through end-to-end manufacturing capabilities across 15 global 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.


PPS offers end-to-end development and manufacturing solutions through a globally integrated network of facilities across the drug life cycle to innovators and generic companies. PCC's complex hospital product portfolio includes inhalation anaesthetics, intrathecal therapies for spasticity and pain management, injectable pain and anaesthetics, injectable anti-infectives, and other therapies. The Indian Consumer Healthcare business is among the leading players in India in the self-care space, with established brands in the Indian consumer healthcare market. In addition, PPL has a joint venture with Allergan, a leader in ophthalmology in the Indian formulations market. In October 2020, the company received a growth equity investment from the Carlyle Group.