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Executive - Quality Review Team

6.00 to 8.00 Years   Vishakhapatnam   20 Jun, 2021
PFIZER LIMITED
Job LocationVishakhapatnam
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaQuality (QA-QC)
EmploymentTypeFull-time

Job Description

Responsible to review the manufacturing and Quality control documents

  • Fundamental knowledge on manufacturing and Quality control activities, such as Solution preparation, filling, terminal sterilization, visual inspection, packing, in process sampling and analysis.
  • Knowledge in change control assessment
  • Effective communication with all staff from different levels and builds constructive and effective relationship
  • Review of product & process related SOP & Forms
  • Should have trouble shooting abilities in manufacturing & quality control area, which helps the organization to develop, implement and achieve its mission, vision and values
  • Report any non-compliance to the Supervisor
Why Patients Need YouEverything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.What You Will AchieveYou will be a member of Pfizer s dedicated and highly effective quality assurance team. You will evaluate and review Pfizer s clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.How You Will Achieve It
  • Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
  • Create, review and approve Good Manufacturing Practices {also cGMP} audit reports.
  • Review and approve Manufacturing and Packaging records to ensure that the information and documentation conforms to Pfizer policy and cGMPs.
  • Create, review and approve deviations and consistently produce quality work.
  • Accurately communicate supply, operational needs or Quality Operations (QO) perspectives and escalate issues with potential market or stability impact.
  • Ensure that all documents received in the batch release area reviewed for completeness and accuracy.
  • Provide Real Time Quality impact assessments and decisions on product and medical device issues, independently.
  • Maintain inspection readiness, support inspections from regulatory agencies & customers and improve quality assurance systems.
  • Participate in Green/Black belt projects, Right First Time (RFT) Improvement projects, Corrective Action / Preventative Action Effectiveness, etc. as appropriate.
  • Assist and support the manufacturing/packaging staff in detecting and solving compliance errors in real time during manufacturing and packaging operations.
  • Help to define appropriate action plans for improvement and follow-up and communicate action closures.
  • Lead/Participate in Quality Risk Management (QRM) assessments that gain approval through Site and Area Quality Operations (QO) Management.
QualificationsMust-Have
  • Degree in B.Pharm/M.Pharm/M.Sc
  • Experience in pharmaceutical industry: 4 6 years of experience in Quality Assurance / Quality control of sterile dosage manufacturing facility.
  • Experience in Quality administered systems
  • Sound knowledge of current Good Manufacturing Practices {part of GxP}
  • Ability to work in a team environment within own team and interdepartmental teams
  • Effective written and oral communication skills
Nice-to-Have
  • Experience at a manufacturing site
  • Experience of writing and managing deviations
  • Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management
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 Control #LI-PFE,

Keyskills :
root cause analysisstatistical process controlenterprise resource planningquality controlrisk managementprocess controlquality assuranceresource planningcorrective actionvisual inspectionquality operations

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