Hiring for multiple sub-functions of engineering department. Candidate should have worked for sterile formulations company of pharmaceutical industry
1) Understand and develop immediate release and modified release oral formulations for regulated markets (US and EU market); 2) Handling equipment’s for solid oral dosage forms. 3) Troubleshoot in existing products and optimize the process; Required Candidate profile 4) Knowledge of using Design Expert/Mini Tab QbD Software for development conduct experiments. 5) Preparing reports like PDR, specifications, stability protocols, DoE, Tech transfer & Reports.
Planning and performing of Computer Systems Validation in regulated environment. Respond CSV schedule to ensure all quality, manufacturing and engineering systems remain qualified to current GxP and GAMP5 requirements. IT systems interface Required Candidate profile Working knowledge on US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5. Develop CFR Part 11 csv plans, qualifications test protocols, traceability matrices, reports, IQ/OQ protocols; IT system interface
Complete system administration experience to manage the enterprise grade IT network infra. ( firewalls, Servers, campus core network & cloud services.) VLAN management, IP routing technology, firewall management (Palo alto), IP sub-netting. Required Candidate profile Server, Switches & IT Hardware Maintenance & Troubleshooting; Active directory, DNS, DHCP, Azure AD, MDM & Intune; network topologies; DR process; VMWare & Nutanix virtualization
responsible for inspecting and diagnosing issues with manufacturing machines, providing technical support to machine operators and other team members, and continuously evaluating and suggesting improvements to the maintenance program. Required Candidate profile instrumentation & control systems design & maintenance, Knowledge of process control & measurement technologies LIKE VFD’s , PLC and SCADA - Exp in programming languages such as Ladder Logic, C-script
The applicant if selected will take care of quality assurance of the sterile manufacturing company
Quality assurance, Change management, Change control, APQR's, Media fill, Microbiology Compliance and Documents handling in software
Understand and develop immediate release and modified release oral formulations for regulated markets (US and EU market). Troubleshoot. Knowledge of using Design Expert/Mini Tab QbD Software. 2) Handling equipment’s for solid oral dosage forms Required Candidate profile Preparing reports like PDR, specifications, stability protocols, DoE, Tech transfer & Reports. Patent analysis, develop non- infringing formulations. Troubleshoot existing products & optimize process
Managing the production of tablets. Role and responsibility of Pune and Nigeria tablets manufacturing plant 4 to 5 months in Pune and similarly then in Nigeria. Additional healthy allowances will be paid while of trip to Nigeria Required Candidate profile Applicant should be strong in handling the production of tablets entirely. African regulatory bodies Perks and benefits Speciall allowances and perks for Nigeria time
Managing the production of Ointment. Role and responsibility of Pune and Nigeria Ointment manufacturing plant 4 to 5 months in Pune and similarly then 4 to 5 months in Nigeria. Additional healthy allowances will be paid while of trip to Nigeria.
Handled ANDA submissions with thorough knowledge on review of CMC documents of dosage: Injectables (simple and complex), Ophthalmics, Topicals, Nasal Sprays and Tablets. knowledge on Module 5 requirements with review & upload study reports. Required Candidate profile Experience of eCTD tools - Educe/Lorenz and/or Pharma Ready. evaluate and respond Agency’s Deficiencies. review DMF. USFDA. Experience of handling submissions related to site transfer products
We are hiring people for sterile /injectables/opthalmic production roles at multiple levels Required Candidate profile Should have worked in injectables, opthalmics manufacturing companies
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