AM - Quality Assurance

7 days ago

Roorkee, Uttarakhand, India Jubilant Biosys Full time

Reporting

  • Field alert report logging and associated activity tracking

Product Recall

  • Logging and tracking of product recall related activities in coordination with customer / QP (As Quality Recall Coordinator)

Change Control & Deviations

  • Review, approval and closures of change controls, deviations, CAPA, associated trends, extensions and conducting their effectiveness check in Trackwise (As Quality SME and Quality Contact)

SOPs

  • Review and approval of departmental and other departmental SOPs

Training & Development

  • Review and approval of training plan and impart trainings as per schedule to meet cGMP requirement. To perform role of training coordinator in ComplianceWire

Liaisoning

  • To coordinate with external agency / customer for site audit / visit planning
  • To coordinate with various departments for timely response of customer and regulatory audit observations
  • Coordination for data collection with various departments, data compilation and conducting of Quality Metrics review (As Quality council Coordinator)

Audits

  • Planning, conducting and closure verification of Internal Quality Audits

Batch Records

  • Review of Batch records, Analytical records and approval, release or rejection of the finished drug products for distribution / sale (Usage decision in SAP) in absence of designated person

Customer Service

  • To coordinate with various customer / QP to resolve any queries or to provide required documents

RM / PM / FG

  • Review and approval of raw materials, packaging material and finished product specifications, standard test procedure and GTPs. Approval of analytical work order in SAP

Analytical Records & Stability Data

  • Review of analytical records, Stability data sheet and batch records intended for filling and compliance of documents in line with filled documents, approved ANDAs & MAs

Annual Product Quality Review

  • Review and approval of Annual Products Quality Review

Investigations

  • Review of OOS, OOT and respective investigations
  • Review and approval of temperature excursion investigation report

Risk Assessment

  • Responsible for review and approval of risk assessment, control and communication ",

  • Quality Assurance Engineer

    2 weeks ago

    Roorkee, Uttarakhand, India Miratech Full time

    Company DescriptionMiratech helps visionaries change the world. We are a global IT services and consulting company that brings together enterprise and start-up innovation. Today, we support digital transformation for some of the world's largest enterprises. By partnering with both large and small players, we stay at the leading edge of technology, remain...

  • AM -Packaging Development

    3 days ago

    Roorkee, Uttarakhand, India Jubilant Biosys Full time

    Lead and support the development of innovative, cost-effective, and sustainable packaging solutions in line with brand guidelines, regulatory requirements, and customer expectations.Coordinate with cross-functional teams including marketing, procurement, production, quality, and external vendors to manage packaging projects from concept to...

  • Executive-Production

    3 days ago

    Roorkee, Uttarakhand, India Jubilant Biosys Full time

    Plan, coordinate, and execute day-to-day production activities to ensure output targets are met while adhering to quality, safety, and cost standards defined by the organization.Monitor production schedules, machine utilization, manpower deployment, and raw material availability to minimize downtime, reduce wastage, and improve overall operational...

  • Quality Assurance Analyst

    1 week ago

    Roorkee, India Elite Corporate Solutions Private Limited Full time

    Position Overview: Quality Assurance AnalystASPIA Infotech is looking for a Tester with a strong background in Quality Assurance (QA) analysis, encompassing both manual and automated testing. As a Tester, you will play a vital role in ensuring the quality and reliability of our cybersecurity products and services. You will work closely with our...

  • Quality assurance analyst

    1 week ago

    Roorkee, India Elite Corporate Solutions Private Limited Full time

    Position Overview: Quality Assurance AnalystASPIA Infotech is looking for a Tester with a strong background in Quality Assurance (QA) analysis, encompassing both manual and automated testing. As a Tester, you will play a vital role in ensuring the quality and reliability of our cybersecurity products and services. You will work closely with our development...

  • Quality Assurance Analyst

    1 week ago

    Roorkee, India Elite Corporate Solutions Private Limited Full time

    Position Overview: Quality Assurance Analyst ASPIA Infotech is looking for a Tester with a strong background in Quality Assurance (QA) analysis, encompassing both manual and automated testing. As a Tester, you will play a vital role in ensuring the quality and reliability of our cybersecurity products and services. You will work closely with our development...

  • Quality Assurance Executive

    5 days ago

    Roorkee, India Helax healthcare pvt.ltd. Full time

    Need quality Assurance documents for pharma Pay: ₹10,550.41 - ₹58,638.55 per month Schedule: - Day shift **Education**: - Bachelor's (preferred) **Experience**: - total work: 1 year (preferred) Work Location: In person

  • Quality Assurance Executive

    2 weeks ago

    Roorkee, India Amorvet Full time

    **JOB DESCRIPTION: - ** **1.......Identifying and correcting defects**: Working to identify and fix problems in the production process to improve the quality of products. **2......Recording and managing deviations**: Recording and managing deviations in manufacturing and distribution **3......Recording and trending complaints**: Recording and trending...

  • Quality Assurance Executive

    1 week ago

    Roorkee, India Pyrax polymars Full time

    v **Preparation of documentation for submission to INDIAN FDA** v **(CDSCO, NEW DELHI) for medical device mfg. certificate approval.** v **FDA / CE / ISO 13485 - Screening of documents, compilation of dossier & drafting of letters and justifications.** v **Internal-External audit compliances** v **Coordination with various consultants for preparation of...

  • Divisional Quality Excellence Lead

    2 weeks ago

    Roorkee, India V-Guard Full time

    KEY RESPONSIBILITIES -Leads the operational excellence and quality efforts in strategy and business objectives. -Introduces and implements structured and disciplined methods and tools for continuous improvement of manufacturing. -Initiate and Facilitate TQM across division Manufacturing plants -Drives "bottom-line" performance improvement in critical...

  • Divisional Quality Excellence Lead

    2 weeks ago

    Roorkee, India V-Guard Full time

    KEY RESPONSIBILITIES-Leads the operational excellence and quality efforts in strategy and business objectives.-Introduces and implements structured and disciplined methods and tools for continuous improvement of manufacturing.-Initiate and Facilitate TQM across division Manufacturing plants-Drives "bottom-line" performance improvement in critical operational...

  • Divisional quality excellence lead

    2 weeks ago

    Roorkee, India V-Guard Full time

    KEY RESPONSIBILITIES -Leads the operational excellence and quality efforts in strategy and business objectives. -Introduces and implements structured and disciplined methods and tools for continuous improvement of manufacturing. -Initiate and Facilitate TQM across division Manufacturing plants -Drives "bottom-line" performance improvement in critical...

  • Divisional Quality Excellence Lead

    2 weeks ago

    Roorkee, India V-Guard Full time

    KEY RESPONSIBILITIES-Leads the operational excellence and quality efforts in strategy and business objectives. -Introduces and implements structured and disciplined methods and tools for continuous improvement of manufacturing. -Initiate and Facilitate TQM across division Manufacturing plants -Drives "bottom-line" performance improvement in critical...