Job for Associate Manager in Quality Assurance at USP
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Post : Associate Manager - Quality Assurance
Summary of the Position
This is a nonsupervisory professional position responsible for supporting various Quality Assurance activities in coordination with the QA Department Supervisor to include: Working with all functional heads and coordinating with USPRockville on maintaining the quality management system, preparing SOPs and performing internal audits (ISO/IEC 17025 and ISO 9001). Focus areas internal audits, review of protocols and reports (Equipment IQ/OQ/PQ and AMV), SOPs/ documentation of laboratory funtions and other non laboratory functions such as Strategic Marketing and External Affairs (SMEA), Facilities Management, Information Technology, Human Resources, etc. Conduct project documentation audits (Analytical data reviews) of Reference Standard Laboratory, Analytical Research and Development (ARD), Biologics, Research and development (R&D), Impurities for development (IFD) and Verification program (Chem & Micro).
Roles and Responsibilities
• Project documentation audits.
• Timely completion of project documentation audits (Analytical data review) and release of projects.
• Review and approval of equipment qualification/ validation protocols and reports.
• Maintaining Quality management system:
• Investigation, RCA and timely closure of Laboratory investigation report (LIR), Deviations, Incidents, CAPA and Effectiveness checks.
• Conduct internal audits independently and prepare audit reports.
• Managing supplier evaluation program
• Support QA / other cross functional departments in preparation of external ISO audits.
• Ensure the compliance to ISO standards and internal SOPs.
• Documents and data control:
• Review of SOPs, Department controlled documents, forms, formats and archival of QA documents.
• Quality management system review
• Data collection, evaluation and PPT preparation for Management Review Meetings.
• Prepare trends on QA observations and identify most reoccurring issues and propose appropriate CAPA.
• Supporting supervisor to rollout and implement global initiatives
• Master’s degree in Science with 8 plus years relevant experience in a pharmaceutical industry, preferably working in API or formulations industry.
• Minimum of three (3) years of experience in handling analytical equipment, qualification of analytical equipment, calibration, metrology and other laboratory activities.
• Minimum of two (2) years experience in handling Quality notifications (LIR, Deviation, Incident, Change controls, CAPA, OOS and OOT), Document control, regulatory and/or ISO audits, internal audits and other QA activities.
• Good auditing skills and technical report writing skills
• Knowledge on Analytical Method validations and Microbiology/Cell biology related testing is an added advantage.
• Knowledge on risk based thinking and risk assessment tools
• Working knowledge of MS Word, PPT, Excel etc.,
• ISO 9001 Lead Auditor Certification and knowledge of ISO 17025
• Any QA/QC course/certifications such as Diploma in Pharmaceutical Quality Assurance, Comprehensive Course in Quality Assurance and Control Systems, Good Documentation Practices, Data integrity, Investigations (Root Cause Analysis) and risk assessment is an added advantage.
• Understand of GMP, GLP, and ISO regulations and the integration of the regulations into working systems in the laboratory.
Experience : 5+ years
Qualification : M.Sc
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality Assurance
End Date : 30th January, 2020
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