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Associate Quality Support LCZ operations

3.00 to 6.00 Years   Chennai   10 Jul, 2021
PFIZER LIMITED
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaOperations Management / Process Analysis
EmploymentTypeFull-time

Job Description

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 and control team. You will be responsible for activities involved in developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and agency guidelines. Your contribution in quality risk management will help us in commitments tracking, interpreting policies, manage site complaints and work directly with operating entities to provide process analyses oversight.Thanks to you, we will be prepared for all upcoming audits and inspections. You will be relied on to ensure that the quality assurance programs and policies are maintained and modified regularly. You will make sure that there are uniform standards worldwide and best practice sharing, which will help in fostering the achievement of companys mission globally.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

  • Recognize and anticipate the Laboratory s needs, and coordinate activities required from Quality Control (QC) in the transfer of products and perform product quality review.
  • Prepare, review and approve deviation reports and change controls.
  • Provide input to management on utilization, rates, and expenses.
  • Provide technical support and training on new testing, systems and techniques.
  • Perform water analysis and tests, such as Microbial Limit Test, Sterility tests, etc.
  • Perform local release of imported products, in compliance with the applicable local regulations and local procedures, prior to distribution/sale within country.
  • Maintain dehydrated and prepared media stocks, master Cultures Isolates and prepare Cryo vials.
  • Review testing equipment and ensure electronic systems work properly, manage validation of new/existing equipment and perform calibration of all the instruments.
  • Manage receipt, storage and handling of Bioball cultures, and bioburden and endotoxin (LAL) Test Kit.
  • 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.
QualificationsMust-Have
  • Bachelors Degree
  • Demonstrated working knowledge and understanding of laboratory procedures, sample processing / analysis, and lab calculations
  • Working knowledge of contemporary analytical techniques
  • Knowledge of Good Manufacturing Practices {also cGMP}, validation principles, audit techniques, and working knowledge of statistics
  • Effective communication skills, both verbal and written
Nice-to-Have
  • Knowledge of drug/device combination product requirements
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 :
microbial limit testequal employment opportunitycontinuous improvement facilitationwater analysisquality controlrisk managementproduct qualitytechnical supportquality assurancecommunication skills

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