Pfizer – Vizag is looking for women leaders in Quality function (Microbiology – Manager/ CI Specialist/ Quality Control/ Quality Training/ Assocate – MQA) Apply Now
Quality Control – Microbiology – Manager
•Master’s Degree in Microbiology with 15+ years Provide guidance, lead/ co-lead projects, manage own time to meet
objectives, and plan resource requirements for projects across the division.
→ Liaise with business stakeholders to define, design and implement performance measures
methodologies
-Deliver continuous improvement projects using six sigma and lean
• Develop and execute IMEx (Integrated Manufacturing Excellence) initial Implementation and updates going forward. Coach/ facilitate/ lead project teams, assist in OpEx strategy definition, solve problems, and implement solutions to improve operational
performance by applying the appropriate tools
•Understanding and proficiency in Change Management
Bring in improvements to ensure adequate data integrity controls are maintained in the lab. Bring in improvements to drive on-time completion of Change actions as
per timelines
Quality – CI Specialist
Collect the data of quality operations losses. Analyze and identify CI projects
Contribute to the completion of moderately complex projects.
Manage own time to meet agreed targets, develops plans for activities on own projects
Develop proposals for improving Site process technology from a quality, cost and capacity optimization perspective.
•Inspire a culture of continuous improvement by partnering effectively with personnel involved in the investigation process
• Lead, support and coach data analysis by using and fostering the adequate OpEx tool
- Lead relevant shared investigations with technical, compliance, operations process team members Identify, analyze, prioritize and execute business solutions.
- Support Quality and Safety investigations through coaching on Six Sigma and preform safety inspections.
Quality Control- Manager
• Master’s Degree with 15+ years Provide guidance, lead/co-lead projects, manage own time to meet objectives, and plan resource requirements for projects across the
division. → Liaise with business stakeholders to define, design and implement performance measures
-Deliver continuous improvement projects using six sigma and lean methodologies
•Develop and execute IMEx (integrated Manufacturing Excellence) initial Implementation and updates going forward. Coach/facilitate/lead project teams, assist in OpEx strategy definition,tools solve problems, and implement solutions to improve operational performance by applying the appropriate tools
•Understanding and proficiency in Change Management
• Knowledge & experience on the QC process flow including RM, PM, IP/EP, Stability, Retention, Calibration, Qualification & Validation to drive appropriate projects to drive improvement in the Lab.
Bring in improvements to ensure adequate data integrity controls are maintained in the lab -Bring in improvements to drive on-time completion of Change actions as
Quality Training – Manager
Master’s Degree with 10+ years
Provide guidance to teams and lead/co-lead moderately complex projects
• Perform needs assessments and audience analysis to define the problem/ opportunity and identify the discrepancies between current and desired performances
•Provide guidance to leadership to help establish role specific training curriculum and lead the implementation of appropriate training formats.
• Collaborate with business partners to produce innovative learning strategies, training methodology identification (on-the-job training, skill assessments, knowledge assessments, elearning courses, etc.), performance support needs (procedures, job aids, work instructions and video), or other solutions, as needed.
Experience in handling LMS administration
Associate Manager-QA
B. Pharm/ M. Phmarm/ M. Sc wih 5 plus years of exepereince investigations
•Review and approve the investigations related to Material management. Review and approve the investigations related to Quality control lab Apply Pfizer standard investigation tools-Method 1, PHP, ER/ QAR content
guideline, CAPA ranking selection tool and ensure timely closure.
-Manage investigations and apply relevant and necessary actions/systems to ensure appropriate levels of compliance.
Ensures that report compliance to relevant regulations, standards and site/ global procedure. Ensure corrective and preventive actions are aligned with the root cause
Effectively track all the open and aging CAPAS/EV, establish effective communication with the functional leads
•Ensure investigations are evaluated and closed in a timely manner to meet business needs
To identify gaps and involve in Process and Procedure Simplification, thereby reduce downtime and increase the Efficiency
Experience in handling regulatory, corporate and internal auditors/ inspectors Evaluate data, trends and report results to management
Review of Change controls and perform impact assessment related to material management.
Assocate – MQA
B.Pharm/ Mpharm, MSc/ Microbiology/Chemistry) with 1 to 2 years of experience
Responsible for ensuring operating state of cGMP compliance in solution/emulsion preparation, vial/ ampoule washing, depyrogenation, filling and capping operations
Maintain regulatory compliance in accordance with cGMP practices
•Ensure manufacturing policies and procedures conform to Pfizer standards
• Knowledge and hands on experience in reviewing eBR and assessing the impact of AMPs exceptions with technical support/inputs from Sr. Specialist or Supervisor Review of batch reports and equipment audit trails
Ensure start-up and in-process activities performed as per batch record and SOP compliance
Please send resume to [email protected]
Please share resume to [email protected]