JOB OVERVIEW:
The Business Analyst & Project Management role specializes in analyzing, documenting, and facilitating the implementation of projects like Learning Management Systems (LMS), Electronic Forms Management (E-forms), Document Management Systems (DMS), E APQR, MES and Validation Learning Management Systems (VLMS). This role involves collaborating with stakeholders to gather and analyze requirements, translating business needs into technical specifications, and ensuring successful delivery and adoption of application solutions. This role also requires to lead and support digital transformation initiatives within the Piramal pharma Limited. This hybrid role is ideal for someone with strong analytical capabilities, project management expertise, and a passion for leveraging digital technologies to improve operational efficiency, and compliance.
KEY STAKEHOLDERS: INTERNAL
- Business – Site / Corporate functions
- IT Team (e.g. SAP/ Infra / Quality IT / Allied / SAP Basis/ CSV/ QeC)
KEY STAKEHOLDERS: EXTERNAL
- IT Vendors
- IT Contractors/Consultants
REPORTING STRUCTURE:
- Reporting Associate General Manager – QeC
QUALIFICATION:
- Graduate in Science/Pharmacy/Engineering
- Post Graduation – Science/MBA (Desirable)
EXPERIENCE:
- Candidate with 8 to 12 years of Program management experience in Pharma/Life science domain working on of Learning Management (LMS), E-Forms using LCNC platform, Document Management System (DMS), Validation Lifecycle Management System (VLMS), E-APQR, MES.
- Work experience in both IT Sector and Pharma Sector will be desirable.
SKILLS AND COMPETENCIES
- Act as a business analyst for implementation and lifecycle management for various Pharma GxP applications and ensure seamless integration with other site and enterprise applications.
QUALIFICATION:
QUALIFICATIONS
- Graduate in Science/Pharmacy/Engineering
- Post Graduation – Science/MBA (Desirable)
- Strong knowledge and hands-on experience Pharma GxP system and its implementation.
- Identify opportunities of process harmonization across organization.
- Collaborate with key stakeholders to understand business requirements and delivering process solutions to business, proficient in analyzing and translating Business/Process requirements to technical requirements.
- Facilitate communication and coordination between sites utilizing GxP applications, ensuring consistency and standardization in processes and procedures.
- Develop and deliver end-user training programs and materials to support the adoption and utilization of the Pharma GxP applications and its integration with other systems.
- Coordinate UAT activities with stakeholders, ensuring comprehensive testing coverage and validation of system functionalities.
- Escalate complex technical issues to the appropriate IT or support teams for resolution.
- Stay informed about latest system updates, new releases, and industry trends, and make recommendations for system improvements and optimizations.
- Establish and maintain effective relationships with business team, project stakeholders, vendors, consultants, and external partners to leverage expertise and resources as needed.
- Monitor and report on quality system performance, usage, and effectiveness, and make recommendations for continuous improvement.
- Lead the planning, execution, monitoring, and closure of digital transformation projects.
- Define and track KPIs to measure the impact of digital transformation projects.
- Develop detailed project plans including timelines, milestones, resource allocation, and risk mitigation strategies.
- Proactive approach to problem solving and suggest process improvements in Business Processes.
SKILLS AND COMPETENCIES:-
- Excellent communication and interpersonal skills, with the ability to effectively engage and influence stakeholders at all levels of the organization. (Must)
- Experience as a Business analyst/SME of various GxP and its integration with other systems roll out and operational support (Must).
- Strong analytical and problem-solving skills, with the ability to translate complex business requirements into actionable solutions. (Must)
- Proven ability to manage multiple priorities and complex projects. Adaptability in a fast-paced, evolving digital landscape. (Must)
- Experience of working at Pharma Site – QC, QA, IT, CSV etc. (Plus)
- Experience of validation on automation/digitization projects (Plus)
- Knowledge of pharmaceutical processes and data analytics. (Plus)
- Functional knowledge of Regulatory guidelines, Quality Control and Manufacturing processes. (Plus)
- To have understanding of regulatory requirements and guidelines required to comply IT systems in Pharma industry – DI, Part 11, Annex 11, GAMP 5 etc.
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 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.
