ORKA
WHAT WE DO
We provide strategic pharma consulting where deep regulatory knowledge meets technical execution. Our integrated solutions de-risk validation, digital, and manufacturing projects, ensuring compliance becomes your advantage.
Knowledge Based CQV
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Scientific and Risk-based approach to CQV to processes, equipment and facilities
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Product-centric approach to qualification and validation testing taking into consideration CPP and CQAs
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Strong understanding of shopfloor and laboratory requirements
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Application of ASTM-E2500 to both equipment and computerised system testing
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Strong understanding of ISA S88.01 guidelines in CQV of automation systems
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Expertise cover: Fill Finish and Sterile manufacturing, drug product and drug substance manufacturing, biologics, chemical API, DCS, HVAC, utilities.
CSA/CSV
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Structured, risk-based and practical approach to CSV / CSA
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Expertise gained through deep experience with traditional / legacy system, SaaS and cloud applications such as Veeva and Tulip
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Capabilities span from on-premise to cloud-based systems
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Sustainable validation lifecycle focused mindset
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Expertise cover: MES, eBR, LIMS, LES, Historian, EQMS, DMS, TMS
Smart Factory
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Manage the implementation of digital systems implementation on single and/or across multi-sites
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Project planning, detailed tasks planning, track project progress, schedule, budget, scope and provide project plan forecast.
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Stakeholder Management - Interface with key customers, vendors, contractors, and cross functional teams
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Risk Management - Undertaking risk mitigations and effective deployment of action plans.
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Vendor Management - Interface with vendors and contractors for the project / resources scope, schedule.
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Systems covered: MES, eBR, Historian, LIMS, LES, EQMS, DMS, TMS, etc