Natco Pharma Limited is a vertically integrated and R&D focused pharmaceutical company engaged in developing, manufacturing and marketing of finished dosage formulations (FDF”) and active pharmaceutical ingredients (“APIs”). Natco Pharma Limited was incorporated in the year 1981 and today has eight manufacturing facilities spread across India consisting of over 4500 employees.
Greetings from Natco Pharma Ltd..!! We are looking for the following
- Department : Global CQA
- Position : Subject Matter Expert – Analytical Assurance & CSV
- Experience : 11 to 15+Years
- Qualification : B.Pharm, M.Pharm, M.Sc
- Work Location :Hyderabad
Interested and Relevant experienced candidates can share CV’s at [email protected]
Job description
Preferred candidate profile
- Proficiency in Analytical / CSV / CSA aspects.
- Extensive experience in laboratory analysis and relevant QMS / 21 CFR part 11, EU Annexure 11 / Gamp5 concepts
- Previous experience as a Subject Matter Expert (SME)
- Familiarity with regulatory guidelines is essential
- Thorough understanding of Good Laboratory Practice and Validation of Computer systems & Lifecycle management concepts
- Exposure to the Corporate Quality Assurance (CQA) will be preferred.
Key Accountabilities for SME Analytical Assurance
- Responsible for gap assessment, impact assessment, development, and implementation of harmonized policies and procedures in analytical domain.
- Responsible for Review, and approval of Investigations of OOS, OOT and Laboratory Incidents.
- Responsible for the review of raw materials, packaging materials, process validation samples, cleaning validation samples, hold time study samples, in-process samples, finished products, and stability samples analysis data, both paper and electronic & specifications, methods of analysis, and analytical raw data sheets.
- Possess a thorough knowledge of instruments such as HPLC, GC, dissolution apparatus, disintegration apparatus, UV spectrophotometer, KF titrator, XRD, and ICP-MS and including method validations and method transfers.
- Provide subject matter expertise to all formulation/API site(s) personnel on aspects of Analytical Operations and their continuous improvement.
- Responsible for the review of working standards and primary standards handling and indent, receipt, usage, and destruction of columns.
- Responsible for the review of analyst qualification documents and their day-to-day activities.
- Responsible for the review of electronic data to ensure no data integrity issues.
- Responsible for the review of Qualifications, Calibration and Performance verification of laboratory instruments and equipment.
- Responsible for ensuring adherence to the ALCOA+ principles in laboratory operations and ensure that all laboratory electronic applications comply with 21 CFR Part 11, EU Annex 11, and GAMP 5 standards.
- Responsible for the review of handling retention samples of raw materials and packaging materials.
- Responsible for reviewing assigned shelf life and relevant stability data.
- Identifying the training needs of the teams and Conducting need base training programs.
- The interface between various customers and internal teams during technical presentations/ technical gatherings
Key Accountabilities for SME – CSV
- Responsible for gap assessment, impact assessment, development, and implementation of harmonized policies and procedures for all Computerized Systems.
- Responsible for Review of Life Cycle phases of Computerized Systems such as Planning: Specification, configuration & coding, verification and Reporting and Release.
- Responsible for reviewing supplier qualifications and conducting periodic evaluations of computerized systems.
- Responsible for reviewing requirement specifications, functional specifications, design specifications, module (unit) specifications, code modules, module (unit) testing, integration testing, functional testing, and requirements testing.
- Responsible for periodical review of validated computerized systems.
- Responsible for review of Back up and Restoration processes.
- Responsible for review of Audit Trail Review
- Responsible for review of Equipment/Instrument alarms.
- Responsible for the review of Change Management of Computerized Systems.
- Responsible for the review of validated computerized system Retirement plan and its reporting.
- Responsible for review of classification of computerized systems.
- Responsible for review of all QMS documents relevant to Computerized systems.
- Responsible for review of assigned privileges for computerized systems and their appropriate usage
- Identifying the training needs of the teams and Conducting need base training programs.
- The interface between various customers and internal teams during technical presentations/ technical gatherings
Interested and Relevant experienced candidates can share CV’s at [email protected]
