Senior Manager

7 days ago

Mumbai, Maharashtra, India Piramal Enterprises Full time
Job Description

Job Description :

Business: Piramal Critical Care
Department: Information Technology
Location: Kurla
Travel: Low

Job Overview

To perform and document Computer System Validation of GxP Systems as per defined processes at Central Partner Functions and across Piramal Critical Care sites.

Key Stakeholders: Internal

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

Key Stakeholders: External

IT Vendors, IT Contractors/Consultants, Piramal CSV Partner

Reporting Structure
Reports to: AGM IT - CSV

Education Qualification & Experience

- Graduate in Science/Pharmacy/Engineering
- Post Graduation - MPharm/Science/MBA (Desirable)
- Candidate with 10-14 years of experience in Pharma/Life science domain working on CSV, Part 11/Annex 11, Data Integrity
- Work experience in Pharma or IT Sector will be desirable

Roles & Responsibilities

Must have thorough understanding, practical approaches for Computer system validation (CSV) & Computer Software Assurance 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 end to end CSV deliverables for IT projects e.g. URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, Risk assessment, etc.
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 support Quality Automations Initiatives across the Central Partner functions/PCC/PPL sites.
To liaise with Site IT , Business SPOC's for CSV activities and IT Compliance initiatives.
To guide and train IT & CSV teams (Central Partner Functions & Site) for CSV, and CSV Regulatory Compliance activities.
To work along with Business, IT, QeC & Project Manager to ensure project timelines are met.
Experience on validation of any of the enterprise level applications. e.g. Track wise, Ensur/Documentum, Paperless Validation Tools, LIMS, LMS, SAP, RIMS Applications, Artwork management Systems, Serialization, Veeva etc.
Author, review and approval of SOPs, Guidelines/Policies as applicable.

Competencies

Good knowledge of 21 CFR Part 11 / Annexure 11 (Must)
Good knowledge of CSV, CSA,GAMP 5 Guidelines (Must)
Good knowledge of Data Integrity requirements for Pharma (Must)
Experience in working with various geographical Location Stakeholders such as US, European, APAC. (Must)
Experience of working with Global Pharma Cross functional Sites - QC, QA, Manufacturing, IT, SAP etc. (Plus)
Experience of validation on automation/digitization projects (Plus)
Good Verbal and Written communication skills (Must)
Aware of industry best practices and knowledge about Pharma 4.0 (Plus)
Functional knowledge of CSV 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.)

  • Senior Manager

    3 days ago

    Mumbai, Maharashtra, India Brookdale Senior Living Full time ₹ 15,00,000 - ₹ 20,00,000 per year

    DepartmentRevenue | RevenueJob posted onSep 02, 2025Employee TypePermanentExperience range (Years)5 years - 7 yearsFunctional AreaMaster Team NameSr. Manager – Revenue (Business Strategy & Growth)Emeritus is committed to teaching the skills of the future by making high-quality education accessible and affordable to individuals, companies, and governments...

  • Project Manager

    3 days ago

    Mumbai, Maharashtra, India Brookdale Senior Living Full time US$ 90,000 - US$ 1,20,000 per year

    Sub-DepartmentLearning | DesignJob posted onAug 13, 2025Employee TypePermanentExperience range (Years)5 years - 10 yearsFunctional AreaMaster Team NameAbout the jobOverview of the RoleThe Senior Project Manager – Learning Content for Global Alumni will be responsible for managing the end-to-end delivery of alumni-focused e-learning content projects across...

  • Social Media Manager

    1 day ago

    Mumbai, Maharashtra, India Brookdale Senior Living Full time US$ 90,000 - US$ 1,20,000 per year

    DepartmentMarketing | Brand MarketingJob posted onAug 11, 2025Employee TypePermanentExperience range (Years)7 years - 12 yearsFunctional AreaMaster Team NameAbout EmeritusEmeritus is committed to teaching the skills of the future by making high-quality education accessible and affordable to individuals, companies, and governments around the world. It does...

  • Project Manager

    3 days ago

    Mumbai, Maharashtra, India Brookdale Senior Living Full time US$ 1,00,000 - US$ 1,50,000 per year

    Sub-DepartmentLearning | DesignJob posted onAug 13, 2025Employee TypePermanentExperience range (Years)7 years - 10 yearsFunctional AreaMaster Team NameCompany OverviewEmeritus is committed to teaching the skills of the future by making high-quality education accessible and affordable to individuals, companies, and governments worldwide. We partner with more...

  • Manager - Creative Design

    3 days ago

    Mumbai, Maharashtra, India Brookdale Senior Living Full time US$ 90,000 - US$ 1,20,000 per year

    DepartmentLearning | DesignJob posted onAug 11, 2025Employment typePermanentAbout EmeritusEmeritus is committed to teaching the skills of the future by making high-quality education accessible and affordable to individuals, companies, and governments around the world. It does this by collaborating with more than 80 top-tier universities across the United...

  • Manager - Copywriter

    3 days ago

    Mumbai, Maharashtra, India Brookdale Senior Living Full time US$ 90,000 - US$ 1,20,000 per year

    DepartmentMarketing | Content MarketingJob posted onAug 11, 2025Employment typePermanentAbout EmeritusEmeritus is committed to teaching the skills of the future by making high-quality education accessible and affordable to individuals, companies, and governments around the world. It does this by collaborating with more than 80 top-tier universities across...

  • Senior Manager

    3 days ago

    Mumbai, Maharashtra, India Deloitte Full time ₹ 15,00,000 - ₹ 20,00,000 per year

    Job Title: P2PManager 1) Overview Senior Manager will be responsible for overall ownership and delivery of activities within the Procure to Pay (P2P) function/process, (for e.g., Invoice Processing, Vendor Management, Travel & Expense Management, Accounts Payable) and will be designated as the 'Tower Head' for the P2P function. Key responsibilities for the...

  • Senior Manager

    2 weeks ago

    Mumbai, Maharashtra, India Bathiya Advisors Full time

    Company Description Bathiya Advisors empowers businesses to unlock their true potential with a presence across 15 offices in India and the Middle East. We support Indian and global enterprises as they Progress with Purpose. Our team consists of exceptional professionals from diverse backgrounds, committed to creating meaningful impact for our clients,...

  • Senior Manager

    3 weeks ago

    Mumbai, Maharashtra, India Bathiya Advisors Full time

    Company DescriptionBathiya Advisors empowers businesses to unlock their true potential with a presence across 15 offices in India and the Middle East. We support Indian and global enterprises as they Progress with Purpose. Our team consists of exceptional professionals from diverse backgrounds, committed to creating meaningful impact for our clients,...

  • Senior Engineering Manager

    7 days ago

    Mumbai, Maharashtra, India beBeeEngineering Full time ₹ 14,56,000 - ₹ 15,67,000

    Senior Engineering ManagerWe are seeking a highly skilled and experienced Senior Engineering Manager to oversee the operation of all engineering systems in our hotel.