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3 Days Left : Associate - CQ

3 Days Left : Associate - CQ

PfizerIndia
3 days ago
Job description

Role Summary

Data analysis, statistical modelling, and data visualization of stability studies. Applying statistical methods to identify trends, interpret data, and support organizational objectives.

Key Responsibilities :

Data analysis

  • Conducting analytical similarity assessments for the products utilizing various statistical approaches, including Equivalence tests, Quality Range approaches.
  • To extrapolate the available stability data till the shelf life of the established product and to find out the shelf life of the new products. Further, to perform the Shelf-life analysis for legacy products.
  • To establish provisional trend limits based on the finished product data.
  • To find out the root cause for Out of Trend or Out of Specification batches by considering the trend of respective product and then apply appropriate statistical tools.
  • To perform statistical evaluation for the Out of Trend or Out of Specification batches to make a batch disposition decision.

Retention sample management

  • Receiving and maintaining retention samples of raw materials, packaging materials and drug products.
  • Monitoring of temperature in retention area as required.
  • Ensure retention samples are stored under the recommended storage conditions.
  • Issuance of samples as required.
  • Stability management

  • Preparation of stability protocols.
  • Loading stability samples as per the protocols and procedure.
  • Withdrawn stability samples for the time frame and send samples to QC for testing.
  • Compilation of stability data.
  • GDP and GLP practices

  • To follow Good laboratory Practices.
  • To follow Good Documentation Practices as per ALCOA principles.
  • Follow 5S practices in CQ laboratory.
  • Core Competencies

  • Expertise in handling statistical analysis.
  • Expertise in handling stability management.
  • Expertise in handling retention management.
  • Knowledge of regulatory requirements, USP / EP and other pharmacopeia guidelines.
  • Standards, Processes & Policies

  • Understanding of cGMP, GDP and GLP in Pharmaceutical Industry.
  • Experience in the preparation of stability protocols, compilations, reports, and qualification protocols.
  • Understanding SOP's, Specifications, test Procedure and other documents commonly used.
  • Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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