Associate MQA Downstream

Pfizer; Visakhapatnam; On-site; INR 400,000 - 600,000; Full time

Job summary

Ein Pharmaunternehmen sucht einen MQ TS Downstream Associate in Visakhapatnam. In dieser Rolle sind Sie für die Qualitätssicherung in der Terminalsterilisation, Sichtprüfung und Verpackung verantwortlich. Ideale Bewerber haben einen B. Pharm-Abschluss und 2-6 Jahre Erfahrung in der Pharmaindustrie. Zu den Aufgaben gehören die Einhaltung der Regeln zur guten Herstellungspraxis (cGMP), Qualitätstests und die Dokumentation von Prozessen. Das Unternehmen bietet eine inklusive Kultur und gute Entwicklungsmöglichkeiten.

Qualifications

• 2-6 Jahre Erfahrung in Manufacturing Quality Assurance oder Produktion.
• Erfahrung in der Pharmaindustrie und Qualitätssystemen.
• Fundierte Kenntnisse der aktuellen Guten Herstellungspraxis.

Responsibilities

• Sicherstellen der cGMP-Compliance in der Produktion.
• Überwachung der Terminalsterilisation, Sichtprüfung und Verpackungsprozesse.
• Durchführung von Qualitätsprüfungen und -bewertungen.

Skills

Teamarbeit

Kommunikationsfähigkeiten

Troubleshooting-Fähigkeiten

Kenntnis in GxP

Education

B. Pharm oder ein Wissenschaftsabschluss

Job description

Associate MQA downstream page is loaded## Associate MQA downstreamlocations: India - Vizagtime type: Vollzeitposted on: Heute ausgeschriebenjob requisition id: 4949895**Use Your Power for Purpose**Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard. Your role is crucial in maintaining this commitment and driving forward our mission to improve patient outcomes.**Role Summary:**The MQ TS Downstream Associate is responsible for primary contact of quality on the floor, particularly in the Terminal sterilization, Visual Inspection and Packing areas of production and monitor processes for compliance to cGMP standards. **Job Responsibilities:**Responsible for ensuring operating state of cGMP compliance in Terminal Sterilization, Visual Inspection and Packaging operations.Maintain regulatory compliance in accordance with cGMP practicesEnsure manufacturing policies and procedures conform to Pfizer standardsKnowledge and hands on experience in reviewing eBR and assessing the impact of AMPs exceptions with technical support/inputs from Sr. Associate or Sr. Team Leader.Review of Batch reports and Equipment audit trails.Perform Acceptable Quality level sampling, Inspection in VIDT and Batch record review and release.Perform batch start-up and end activities viz. sensor challenge tests, recipe review etc.Perform random process checks for Terminal Sterilization, Visual Inspection and Packaging.Perform Daily walkthroughs and report observations to the Sr. Team Leader.Perform Equipment breakdown assessments w.r.t to Product Quality and patient safety with technical support/inputs from Sr. Associate or Sr. Team Leader.Review and assessment of equipment alarms and review of quarterly alarm trends.Report any non-compliance to the Sr. Associate or Sr. Team Leader.Should have trouble shooting abilities in manufacturing area, which helps the organization to develop, implement and achieve its mission, vision and values.Identify gaps and involve in Process and Procedure Simplification, thereby reduce downtime, and increase the Efficiency. **Here Is What You Need (Minimum Requirements)*** B. Pharm any science degree* 2-6 years of experience in Manufacturing Quality Assurance / Quality Assurance / Production of a pharmaceutical manufacturing facility.* Experience in the pharmaceutical industry and Quality administered systems* Sound knowledge of current Good Manufacturing Practices (part of GxP)* Ability to work effectively in a team environment, both within one's own team and interdepartmental teams* Effective written and oral communication skills. Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Quality Assurance and ControlKarrieren bei Pfizer sind einzigartig. In unserer Kultur der individuellen Verantwortung glauben wir an unsere Fähigkeit, die Zukunft der Gesundheitsversorgung zu verbessern und an unser Potenzial, viele Millionen Leben zum Besseren zu wandeln. Wir suchen stets nach neuen Talenten für unsere globale Gemeinschaft, um gemeinsam neue innovative Therapien zu entwickeln, die die Welt zu einem gesünderen Ort machen.