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| Job Location | Bangalore |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | Quality (QA-QC) |
| EmploymentType | Full-time |
Quality Systems - LeadGrade19 - 20DepartmentQuality AssuranceReporting SupervisorSite Quality Operations LeadLocationVisakhapatnam3. Educational Qualifications and Work ExperiencePreferredQualificationMaster s Degree in Sciences/ Pharmaceutical SciencesTarget years of experienceMore than 10 years of experience in Pharmaceutical Manufacturing Operations/ Quality SystemsOther CertificationsNone4. Knowledge and SkillsTechnical SkillsUnderstanding of Pharmaceutical Manufacturing, Packaging, Quality Assurance, and Quality Control operations.Knowledge of Regulations/ Guidance s, Good Laboratory Practices, Good Manufacturing practices and ICH Guidelines.Standards, Processes & PoliciesKnowledge of GMPs and regulations governing manufacturing operations for sterile products including aseptic processingBehavioral/Any Other SkillsGood interpersonal and communication skills.Must be able to interact effectively with all levels of site and corporate personnel.Demonstrate analytical thinking ability to evaluate complex issues and provide effective solutions.Effective project management skills and demonstrated ability to manage multiple competing priorities.. ResponsibilitiesEstablish, where necessary and/ or ensure an effective Quality Systems is available at the site which meets the Regulatory requirements.Lead Quality Systems that includes Documentation Lifecycle management, Change Management process, Quality Metrics review, Pfizer Quality Standards (PQS) Implementation and global Quality Tracking System (gQTS) and ensure the Systems are in compliance with the requirements.Lead the establishment of Quality objectives including establishing top level performance Metrics that will drive Quality improvements.Analyse Quality performance metrics for site and above site level.Ensure effective implementation of Pfizer Quality Standards (PQS) in Coordination with Site PQS Coordinator.Lead the Quality Systems projects (PDOCS, gQTS etc.) and deploy strategies for monitoring the compliance of implemented quality systemsLiaise with BT and Central teams for enhancements/ upgrades in Quality Systems databases.Monitor the performance of Quality Systems and present at the site Quality Review Team (S-QRT) meetings.Develop mechanisms for sustainable compliance for implemented Quality Systems.Support the Site Quality Operations Leader in management of Corporate & Regulatory Audits/Inspections.Identify development needs including succession plan for the teams and support their development by coaching and/ or mentoring.Enable the team in setting up SMART goals and empower the teams in achieving their objectives.,
Keyskills :
qualitycontrol qualitysystems qualityassurance changemanagement qualitystandards managementskills projectmanagement qualitymanagement qualityoperations managementsystems ualitymanagementsystems