We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
Business Analyst
Pharmalex is seeking a Business Analyst for a Techno-Functional role.
Location - Noida/Mumbai/Hyderabad
Your Job
- System/Solution ownership from audit readiness perspective
- System change control management in line with GxP guidelines
- Define, review, approve and implement any risk mitigation plans as well as ensuring that the system technical requirements are documented.
- Ensure that adequate procedural controls are in place to maintain the validated state and protect data integrity of systems
- Evaluations for go/no-go decisions of all change requests with potential impacts on security, maintainability, data integrity and architecture
- Defines project/system end to end requirements by identifying key deliverables, phases and acceptance criteria, to guide stakeholders and developers/engineers to help drive the development of new applications and features
- Formulates and defines business scope and objectives of the relevant process area through research and fact-finding combined with an understanding of business system and the industry requirements.
- Performs detailed Functional/data requirements gathering and analysis to provide high quality and detailed requirements, ensuring the closest involvement and agreement from the user community.
- Responsible for overall quality of requirements matching to business solution expectations/ needs.
- Consults with multiple stakeholders (e.g. the sponsor / business users/superusers/process owners etc) to construct the system requirements
- Looks at every problem and our solutions in the eyes of our business users. Works with stakeholders in all business units to formulate scope and objectives for new initiatives. Partners with business stakeholders and business engagement managers to prioritize, analyze, define and manage backlog by gathering enhancement requests and helping with project requests as the business needs evolve.
- Understand current pharma/biotech industry techniques/ conventions, Standard Operating Procedures (SOPs), WPs and project requirements according to regulatory, ICH and GCP guidelines
- Develops System functional requirements documentation in the form of user stories, process flows, and user acceptance criteria, Prototypes/produces system documentation data models, data flows, and process flows.
- Explain customer’s requirements correctly to the internal implementation team. Prepare and explain demo environment of system as necessary for implementation workshops.
- Be a “go to” Subject Matter Expert (SME) for SQRC(Safety, Quality, Regulatory Compliance) Systems area
- Provide an oversight on operational activities to the internal team, and have a strong understanding of budget, and scope of work for assigned projects.
Your Profile
- 6+ Years of experience with at least three years in a similar role
- GxP System Ownership experience
- Experience in developing functional requirement & design specifications for system implementations adhering to GxP compliant standards
- Ability to learn and understand new products and system architecture Project scope definition and scheduling/ tracking experience, understanding of project management methodologies
- Excellent interpersonal skills, including the ability to represent the group in a business/client facing role
- Ability to take responsibility for high quality and on-time project deliveries
- Self-motivated, individual contributor with ability to motivate fellow team members
- Strong negotiating skills.
- Experience of leading RFP process for selection of 3rd party tools
- Vendor portfolio management(including 3rd party software evaluation for procurement, Build vs buy analysis
We Offer
- A collaborative and diverse work environment that values innovation and inclusivity.
- Opportunity to join a fast paced growing Global MNC and conquer exciting and varied challenges alongside a talented team
- Ability to work independently and collaborate effectively in a global, cross-cultural environment.
- Flexible working hours striking a good work life balance
- Business interaction with nearly all branches of the company across 5 continents
- A broad range of initiatives for personal development and professional training
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
For further information please don’t hesitate to contact us:
Ms Mayuri Lad
Global Talent Acquisition APAC, Human Resources
Agencies only by prior agreement for the specific job opportunity.