Skilled in MS Office tools like MS Word and MS Powerpoint & MS Excel (filters, formulas, pivot tables, charting)
Good command of PMO and SPOC
LMS, LIMS, SAP for billing, pass-through cost
Agile methodologies, SDLC and software methodologies, JIRA
Management knowledge
Financial management
Planning & organizing
Business planning
Progress reports
Risk management
Procedure Implementation
Summary
Having 11 years work experience in project management. Specialist in trouble shooting, planning and execution of project, resource management, budgeting costing analysis, conflict management. Worked for Microbiology, Biology, Formulations & Analytical departments in GMP environment and USFDA approved laboratories. Rich with quality experience with technical and management system. Well versed with project deliverable tools like LIMS, SAP, LMS. Familiar with JIRA, Agile & SDLC methodologies.
Work History
Manager
Aragen Lifesciences Pvt Ltd
Hyderabad
06.2019 - Current
Identified project scopes, timelines and budget for the contract development
Identify and communicate project deliverables to all stakeholders
Tracked project performance to analyze successful completion of short- and long-term goals
Engaging internal and external clients to develop logistics concepts and solutions in order to meet study deliverables, objectives and profitability while achieving client satisfaction
Ensure study/project timelines and budgets are met in accordance to the contractual agreement including proactive management and communication of timeline changes to ensure the efficiencies are maximized
Ensure that study specific management tools and documents are in place and constantly maintained
Perform risk assessment and develops mitigation/contingency plans as needed and manages project execution accordingly Prepare, participate in and follow up on audits/inspections
Undertake the full range of project-based duties relevant to the leadership, management, and development of the project team to ensure their performance meets and/or exceeds the requirements to be fulfilled both on the study as well as on a personal goals/objectives level
Develop & manage execution of project or program related clinical supply, sourcing, manufacturing, distribution & laboratory logistics strategy with relevant stakeholders in line with applicable regulations
Communicate with third party providers and negotiates scope of work in conjunction with procurement
Utilize applicable tools for supply chain simulation and forecasting
Develop, plan and manage inventory according to strategy, quantities and forecast
Develop supply schedule, seeks feedback from Clinical team on study progress and adjust accordingly and provide feedback to depots
Develop and implement production, depot and distribution strategy including collaborating with 3rd party depots with relevant stakeholders
Overview the operational management of programs and assets
Ensures study/project timelines and budgets are met in accordance with the contract agreement
Finance and Profitability Management (Monthly, control, input) incl
Client invoicing
Maintain Parexel’s Internal Project controlling/Financial systems including but not limited to monthly revenue and forecasting
Pass Thru Cost (PTC) management with controls and reporting of costs for internal service fees and external providers incl
Invoicing
Monitors the projects status and identify for any potential Change in Scope (CIS) needed in a timely manner
Gather feedback and evaluate on the projects status and identify for any potential CIS (Change in Scope) for professional services and/or PTC needed in a timely manner to ensure that the operational tasks are contractually covered
Follow through on any CIS until signature
Contributes to profitability/finance management (monthly reporting & forecasting, budget control, change in scope management)
Act as main point of contact for internal and external customers and use a consultative approach in issue resolution
Proactively engage with external and internal clients in solution improvements
Work towards establishing positive relationships with internal and external clients
If required actively take part in the bidding process (Proposal, 3rd Party Vendor Selection, Bid Defense, contracts negotiation and review) including client presentations
Represent Parexel at professional meetings/conferences as participant and/or speaker
Assist in managing increased demands and expectations of customers through consistency and predictability in internal procedures and avoidance of crisis situations
Lead project meetings and support team members to monitor and ensure that projects is completed within budget, schedule and according to contract specifications in accordance to the quality standards, SOPs, ICH-GCP, GMP, GxP and/or any other guidelines to fulfil local regulations, including customs regulations
Implement process improvements, including CAPA, in conjunction with the team, in response to corporate, quality issues, client and team feedback and quality audits
Performs risk assessment and develops mitigation/contingency plans as needed and manages project execution accordingly
Ensure that study specific management tools and central file maintenance plan are in place
Ensure project related training are properly assigned to project team members and their timely completion.
Sr. Executive Project Management
Wockhardt Bio AG
Dubai
03.2016 - 06.2019
Develops project plans for all aspects of assigned projects and manages all project activities
Establishes and leads cross functional project teams and status meetings
Obtains consensus and buy-in from key internal and external stakeholders for project timeline
Monitors and manages project scope, budget, forecast, resources, and deliverables within timeline
Maintains up-to-the-minute project action plans and serves as a resource to stakeholders
Develops and mentors project team members
Provides timely, comprehensive project status reports, including budgets and timelines
Ensures all stakeholders receive the required level of detail commensurate with their role
Provides input on strategic goal, tactical planning, and high-level staffing plans.
Senior Executive
AUROBINDO PHARMA LTD
Hyderabad
08.2013 - 03.2016
Activities like Initiation of PNC’s, change controls, exceptions etc., worked with various cephalosporin’s products
Tested Microbial Limit Test, sterility samples, endotoxin samples, gram stain in support of aseptic processing as well as raw material and final product release
Participated in validation activities for compendial microbial methods as well as media fills
Managed test samples according to standard operating procedures (SOPs) & Maintained equipment, reagents and laboratory
Responsible for preparation and revision of SOPs, test methods, batch records, and other controlled documents
Support the development of LIMS and a member of the Project Execution Team for the Microbiology department
Having good exposure in QMS related & Maintain compliance with occupational safety and health, especially regarding hazardous materials/waste
Training coordinator for the monthly Refreshment Training & Adhered to good documentation practices to ensure data integrity and traceability.
Trainee Officer
Natco Pharma Ltd
Chennai
06.2012 - 08.2013
Helped conduct the setup of a new Microbiology Laboratory in the company by writing SOP’s, ordering equipment, contacting various vendors and manufacturers, etc
The following are the duties performed upon completion of the Microbiology Laboratory setup and approval
Responsible for Media preparation and GPT, Microbial Identification & Performed Water analysis and Sampling
Experienced in using bright field light microscope to view and interpret slides.
Carrier Objective
To pursue a challenging career and be a part of progressive organization that gives a scope to enhance my knowledge and utilize my skills towards the growth of the organization by committed and high quality work.
Technical Profile
Java
Academic Qualification
M. Sc. in Microbiology
Disclaimer
I hereby declare that the above-written particulars are true to the best of my knowledge and belief.