Syed Idris Hussaini

About Syed Idris Hussaini

QA expert in Design & Qualification of Drug Substance & Drug Product Facilities for Biologics Manufacturing.• Project Lead QA responsible for ensuring compliance during Qualification of Drug Substance, Drug Product & Quality Control manufacturing & testing suits.• Well versed with regulations in force and internationally accepted guidelines including ICH, EMA, USFDA 21CFR Part 211, 21CFR Part 11/EU annex 11, Schedule M, WHO, ISO and technical guidance documents from ISPE, PDA etc.• Providing strategic program leadership for green field and brown field infrastructure manufacturing projects from conceptualization, qualification till commercial manufacturing.• Proven project management abilities with capacity to design, plan and implement ideas from conception through completion; able to manage multiple projects & responsibilities without compromise to detail or quality.• Hands on experience in creating Validation Master Plans for Process, Cleaning & Facility, SOPs, Process & Cleaning Validation protocols & reports, equipment qualification documents (URS till PQ).• Outstanding interpersonal skills and solid ability to translate technical information and provide training to internal and external stakeholders belonging to varied disciplines.• Very adept in comprehending complex issues and breaking down to simpler achievable tasks, thereby trouble shooting and debottlenecking the projects ensuring compliance and timely delivery.• Good technical writing skills and proficiency in drafting investigation reports, quality risk assessments & audit responses.• Committed to quality; frequently recognized by seniors and peers for strict attention to detail, quick decision-making abilities in critical situations and never give-up attitude.

Experience

1. Project Manager Team Lead Qa

   Dr. Reddy's Laboratories

   Jan 2020 — Present · IN

   Playing vital role in ensuring compliance during C&Q of all Green & Brown field biological drug substance & sterile drug product manufacturing facilities.• Played key role in successfully Designing of Drug Substance & Drug Product suits, Commissioning & Qualification of following facilities,(currently functioning successfully with commercial manufacturing batches) and this also includes complex modifications/expansions of existing manufacturing suites. India’s first Flex Factory Drug Substance facility (Mammalian Cell Culture suite) Drug Product Facility (Automated Vial/PFS Filling Lines & Lyophilizer) Drug Substance suite with Upstream and Downstream suites (All Single use systems) Drug Substance suite with Upstream and Downstream suites (Stainless steel reusable systems) Quality Control unit Modification with C&Q of business critical Drug Product facility in record 3 months’ time (received excellence award for this effort)• Played key role in design and development of non-infringing processes of immunosuppressant and growth factor while being part of Biocon and Dr. Reddy’s respectively. Patents were granted for the innovations.

Education

• Institute Of Chemical Technology

  Master of Technology (M.Tech.), Biotechnology

  2000 — 2002

• National Institute of Technology Warangal

  Bachelor of Technology (B.Tech.), Chemical Engineering

  1995 — 1999

Skills

• Process Capability Analysis
• Troubleshooting
• Manufacturing
• R&D
• Biotechnology
• Regulatory Affairs
• Purification
• Gmp
• Capa
• Fda
• Manufacturing Process Improvement
• Discrepancy Resolution
• Process Validation
• Process Characterization
• Technology Transfer
• V&V
• Process Simulation
• Biosimilars
• Downstream Processing
• Process Capability
• Monoclonal Antibodies
• Chromatography