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Manager Projects (pharma Formulation Projects)

Secunderabad, Telangana
Job Code:
  • Biotechnology & Science
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Job Details

The purpose of this role is to take responsibility for Project Management duties related to the engineering services to be provided by Company for its Client pharmaceutical projects. The projects shall largely be associated with small to medium scale pharmaceutical formulation manufacturing facilities, with some meagre assignments probably pertaining to the API manufacturing domain also. This role will work alongside with the third party Engineering Services provider/s (ESP), to ensure the completion of the defined scope of the engineering services at the required level of quality, time scale and cost. The scope of project services to be managed / executed, shall comprise of but not limited to, Feasibility Study, Concept Design, Basic Engineering Design, Detailed Engineering Design, Turnkey Packages Execution (EPC mode), Facility / Equipment Qualification at Client site, Facility GMP GEP Gap Analysis Assessment, Facility Design Reviews / Due Diligence (GMP GEP compliance perspective), Facility EHS Audits Capital Equipment Procurement, In-house projects related to Project Management Systems, etc. As an additional dimension, this role shall also manage the production procurement for key Company Clientele w.r.t. primary / secondary packing material, APIs, Excipients, etc. in co-ordination with Company SCM representative.Role reports to the VP Projects. No direct reports initially. Project team expansion shall occur in due course, synchronous with the growth of this Service BU in Company.Accountability Primary deliverables of role; its scope; budgetary control (operating/capital), business or people relationshipsKey responsibilities includeo Accountable for project delivery within a stipulated project time frameo Be the Single Point of Contact between Client Project Lead & Third Party ESP Project Manager for implementation of facility engineering scope assignmentso Plan, co-ordinate, perform, monitor, control & deliver the scope of project services enlisted in the KRA section aboveo Understand Clients perspective w.r.t. project objective & transfer the same understanding to third party ESPo Review the fees quoted by ESPs for a given project assignment, based on in-house tentative efforts (man-hours) estimation for a defined project scopeo Provision of regular conceptual inputs to ESP during the course of engineering progress, for critical engineering deliverableso Review all the project deliverables submitted by third party ESP, prior to submission to Client.o Preparation of MS Project based logically linked project scheduleso Co-ordinate with Client & third party ESP to identify and manage risks, issues and changes and acting on resolution with urgency and putting plans in place to ensure monitoring. Escalating to the VP Projects when outside agreed parameterso Accountable for ensuring the projects under execution are on schedule and budget and preparing contingency & recovery plans, if delays or overruns are anticipatedo Identify, track and manage inter-project dependencieso Report on project progress using Progress Update Reportso Ensure Project Office documentation is managed by a defined Document Management Plano Ensure the appropriate use of formal Project and Program Management tools and techniqueso Educate, train as well as provide support and guidance to other team members to make use of the formal Project and Program Management tools and techniqueso Travel within India & overseas to Client office / site for project related activitieso Ability to build and leverage relationships across cultureso Must work well as part of a team and be prepared to carry out a range of dutieso Initiative ability to identify complex issues, understand and act to resolve them with urgencyo Extensive coordination, planning and organization skillso Get involved and pro-actively complete multiple activities as well as learn new activitieso Strong communication skillsComplexityo Degree of change & uncertainty; level of influencing required; degree of matrix workingManaging the complexity of different natured project assignments Managing risks and issues within each project, that may impact upon project scope, timelines or delivery of milestones and working with various stakeholders to resolve the samePlay the role of an effective communication link between various project stakeholders for all project mattersWill be working in a dynamic, pressurised environmentMust be experienced in change environmentHigh level of influencing required with ability to manage multiple small assignments simultaneouslySpecialised Knowledgeo Breadth & depth across disciplines or functions; expertise in field required; separate by basic and preferredBasic RequirementsMust be non-comparative, objective and relevant. Critical/essential to accomplish the roleo Academic Qualification (minimum) B.E. / B. Tech in Mechanical/Chemical Engg. (Mech. Engg. preferred)o Years of relevant professional experience 8 to 10 yearso Experience as a Project Manager in pharma formulation projects involving hands on exposure to facility design & essentially spanning the following FDF manufacturing categoriesSolid Dosage Forms - Tablet, Capsule, Dry Syrup / Powder, GranulesSemi-Solid Dosage Forms Ointment, Cream, Gel, PasteLiquid Dosage Forms Emulsions, Suspensions, Elixirs, Syrups, Lotions, Drops, Mouth washes, etc.Injectable Form Liquid (Vials / PFS), Lyophilized o Ability to independently manage engineering services for pharma formulation facility projects, using third party ESP team as extended arm.o In-depth knowledge w.r.t. the following project engineering disciplines for formulation projectsProcess Plant capacity calculations, Process & Utility equipment sizing; GMP requirementsMechanical Process equipment & piping (incl. layouts) / Utilities (black & clean) / HVAC / FireProtection (FP) & Public Health Engg. (PHE)Building Management Systems & ELV SystemsProject Cost Estimation (upto + 10% accuracy level)o Basic knowledge w.r.t. the following project engineering disciplines for formulation projectsElectricals (other than ELV systems)Plant Instrumentation & Automation (other than BMS)Civil Structure & Architectureo Strong exposure to project capital items procuremento Exposure to & conversant with the requirements of international regulatory body (preferably EDQM, Eu GMP, WHO) facility audits.o Defined as intermediate / advanced in following software skills MS Office (particularly Word, Excel & Power Point), MS Projects. AutoCado Possess profound data base w.r.t. indigenous & imported formulation process & utility equipment machinery vendors & cost.Preferred RequirementsRelevant to the role, but not critical/essentialo Knowledge of the pharmaceutical sterile industry.o Dual exposure of working with Indian Pharma Formulation Major as well as ESP for pharma formulation projectso Exposure of working with turnkey formulation project contractors, in an EPC mode arrangement.o Exposure to Safety & Energy Audits.
Degree: M.Com. (Commerce) | M.Pharm. (Pharmacy) | M.Sc. (Science) | MA (Arts) | MBA/ PGDM | MCA/ PGDCA

Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 8-12


Environment | External Consultant | Formulation | Quality Assurance/ Control
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