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Posted: Jul 12, 2017
Technical Transfer - Manager
Ambernath (Qualification - B.Pharm/M.Pharm | Work Experience - 5+ years in tech transfer, production/technical)
Ensure site readiness in terms of manufacturing and packaging equipment (make, capacity), documentation for validation batches
Ensure that tech-transfer of global formulation projects at CMO sites happens right and on time in terms of transfer of formulation technology and processes
Trouble shoot and provide technical expertise during validation batches and if required during the manufacture of commercial batches during the launch campaign
Preparation of timely technical reports with documentation of key process (manufacturing and packaging) parameter details, following scale up and tech transfer of formulations, trend data for critical process parameters and critical quality attributes as part of the tech transfer exercise
Posted: Jul 12, 2017
Thane (Qualifications - B. Pharma | Work Experience - 5 to 10 years)
Drugs Regulatory Affairs
Review of new product specification and Analytical Procedures for starting
materials, key raw materials, Intermediates and Finished Products.
Review of data received from R&D, manufacturing and analytical departments
of API and Formulation
Responsible for preparing & implementing regulatory submission plan in coordination with Business.
Responsible for final approval of all dossiers for regulatory submissions
To oversee the coordination with consultant/partners and contract manufacturers for product registrations
To get the product Registrations/Re-Registrations in different countries to facilitate the sales operations
To anticipate issues from a reviewer perspective and proactively ensure actions
Responsible for coordinating with the regulatory authorities for site inspections
Travelling to the assigned countries for Product registrations
To coordinate with Business for the dossiers requirement and compliances
To coordinate with Production, Quality Assurance, Quality Control, R&D and Plant-Regulatory Affairs for data generation as per regulatory requirements
Facilitating the manufacturing site inspection & approval incorporation with Business, Quality Assurance & Plant Head
To coordinate with Finance department for the payments to regulatory authorities and for the expenses towards legalization of administrative documents required for dossier compilation
Posted: Jul 10, 2017
Ambernath (Qualification - M. Pharm., M.Sc. | Span of Experience - 5 – 10 years)
Support Generic Drugs Filing in regulated markets (EU, US) for various dosage forms including tablets (conventional and chewable), injectable and oral suspensions
Develop analytical methods and provide technical support to formulation development including in vitro methods development to support bioequivalence assessments
Independently design, execute, monitor, interpret and document analytical activities related to method development, validation and technology transfer
Detailed documentation of analytical activities, method development and validation reports, technical information package for tech transfer, authoring analytical sections in dossiers
Handle queries from regulatory authorities
Develop specifications for raw material, finished product and packaging material in coordination with other project stakeholders
Provide expertise/advise CRO for outsourced project activities
Good knowledge of global stability requirements
Knowledge of identification and characterization of impurities
Should be capable to set up systems like SOPs, Calibration procedures, etc.
Should be familiar with modern analytical techniques like HPLC, GC, dissolution etc.
Posted: May 31, 2017
Manager - QMS
Ambernath (Qualification - M.Sc, B.Sc, B.Pharm or M.Pharma | Span of Experience - 14 – 18 Plus years)
Responsible for Validations, Qualification, QMS, APQR.
Exposure to overall Quality system with QMS, validation, qualification and documentation.
Preparation for Regulatory inspections, compiling inspectional responses and monitoring compliance for solid orals facility.
Conducting surprise compliance inspections / walk through at sites.
Review & approval of Cleaning validation Policy & ensure its implementation
Driving initiative of SME readiness and all time inspection readiness.
Must have exposure towards all the major regulatory Audits.
Review and release of batch processing and packaging records.
To ensure that production operations are carried out in accordance with good manufacturing practices and applicable regulations.
To ensure the awareness of cGMP requirements are evaluated and updated through periodic training and audits.
To co-ordinate with other departments for SOP review and ensure their implementation.
Monitoring and ensuring that GDP are followed in the departments.
Responsible for review and approval of Technical Agreements.
To ensure market complaints are handled as per the SOP and proper investigation is performed with appropriate measures to prevent re occurrence.
To take follow ups with regulatory affairs department for variation filings and approvals.