Zusammenfassung
About the Role
Major accountabilities:
- Coordination and management of analytical method transfers and stability studies. Compilation of data reports
· Life-cycle management of analytical methods, including control of method performance, pharmacopoeia and health authority compliance and definition of method improvements. Handling of deviations, investigation, OOS/OOE/OOT cases as well as changes and complaints
· Perform statistical data analysis to report Out of Expectations (OOE), out of trends (OOT), etc
· SAP master data management: Maintenance of master data, creation of Q-info records and other SAP related activities.
· Validate spreadsheets
· Collect, transcribe and/or compile data from various repositories (SAP, LIMS, external COAs)
· Author, approve and archive Impurity risk assessments – Nitrosamines, residual solvents, etc
· Trend and report all QMS elements as per the request
· Monitor, trend and report Health Safety and Environmental parameters
· Implementation of GMP requirements. Compilation and Review of documents (analytical protocols and reports, annual performance quality reports, ongoing process verification reports, registration documents (Common Technical Document modules)).
· Perform activities of a Quality Control expert as defined by the respective sites
· Support regulatory requirements – routine queries, Chromatogram requests
· Compile Quality performance management decks
· Create and review GxP documents including SOPs, working procedures, trend reports, qualification reports and technical investigations, as and when needed
Key performance indicators:
· On-time and GMP-compliant release of dosage forms -No complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand -Successfully support continuous improvement projects -Executes batch release in compliance with registration
Minimum Requirements:
· Pharmacy/ Science/ MBA / Engineering/ equivalent from a reputed institute
· Min 5 years of experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/ medical devices
· GxP knowledge, Basic IT knowledge
· Good communication, presentation and interpersonal skills
· Experience of working closely with the global stakeholders
Skills:
- Analytical Method Development/ Method Validations/Method Transfers
- Quality Control / In-process / Raw materials /
- Stability studies / Supportive stability studies
- Investigations like OOS/OOE/OOT
- Pharmacopoeia / Health Authority / Regulatory requirements
- GxP / Data Integrity / Quality and Compliance.
- SAP/HPLC/UV
Languages :
· Fluent in English (written and spoken)
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