To perform and author Computer System Validation activities of GxP Computerized as per defined processes at Corporate IT and across Piramal Pharma sites.
KEY STAKEHOLDERS: INTERNAL
•Business – Site / Corporate functions
•IT Team (e.g. SAP/ Infra / Quality IT / Allied / SAP Basis)
KEY STAKEHOLDERS: EXTERNAL
•IT Vendors
•IT Contractors/Consultants
REPORTING STRUCTURE:
Will report to – Chief Manager- IT CSV
EXPERIENCE:
•Candidate with 3 – 6 years of experience in Pharma/Life science domain working knowledge in authoring on Computer System Validation Deliverables, Part 11/Annex 11, Data Integrity
•Work experience in Pharmaceutical Sector will be desirable
SKILLS AND COMPETENCIES
•Experience in Authoring all CSV deliverables e.g. URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, Risk assessment, etc. as per “V” Model for IT projects
•Experience on validation of any of the enterprise level applications. e.g. Trackwise, Ensur/Documentum, LIMS, LMS, SAP/HANA, Chromatographic, Serialization, etc.
•Author, review and approval of SOPs, Guidelines/Policies as applicable.
•To have functional knowledge of Regulatory guidelines, Quality and Manufacturing processes.
•A team player with good communication skills (verbal & written)
KEY ROLES & RESPONSIBILITIES
•To have thorough understanding, practical approaches for Computer system validation (CSV) of enterprise level applications.
•Accountable to ensure compliance of CSV documentation during various phases (project, operational & retirement) of software lifecycle (SLC).Well aware with GAMP5, CFR Part 11/EU Annex 11 and Data integrity requirements.
•To create QMS documents e.g. Change control/Deviation/Incidents-Discrepancy/User access forms.
•To perform Root cause analysis and define CAPA based on QMS documents review.
•To perform periodic and audit trail review of computerized systems as per defined frequency.
•To support the initiatives undertaken by Quality eCompliance and CSV team across the Corporate/PEL sites.
•Perform IT Supplier assessment and ensure compliance of audit observations.
•To liaise with Site ITC SPOC’s for CSV activities and IT Compliance initiatives.
•To guide and train IT & CSV teams (Corporate & Site) for CSV, Data Integrity and Regulatory Compliance activities.
•Knowledge of IT systems and ITIL processes (e.g. Backup/Restoration, Infrastructure qualification, User access Management, etc.)
•Ability to represent during regulatory audits and can able to perform Corporate & DI Audits of sites.
•To work along with CSV & Project Manager to ensure project timelines are met.
Knowledge Required:-
•Good knowledge of 21 CFR Part 11 / Annexure 11 (Must)
•Good knowledge of CSV, GAMP 5 (Must)
•Good knowledge of Data Integrity requirements for Pharma (Must)
•Experience of working at Pharma Site – QC, QA, IT, CSV etc. (Plus)
•Experience of validation on automation/digitization projects (Plus)
•Good Verbal and Written communication skills (Must)
•Good Knowledge on Computer Software Assurance
•Aware of industry best practices and knowledge about Pharma 4.0 (Plus)
•Functional knowledge of Regulatory guidelines, Quality Control and Manufacturing processes. (Plus)
•Knowledge of IT systems and ITIL processes (e.g. Backup/Restoration, Infrastructure qualification, User access Management, etc.) (Must)
•
Qualifications
QUALIFICATION:
•Graduate in Science/Pharmacy/Engineering
•Post Graduation – Science/MBA (Desirable)
About Company
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.
Company
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.
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