Specialist Quality Projects – Pfizer

Specialist Quality projects jobs at Pfizer Ltd. Graduates and post graduates may appy for this. Check out complete details below.

Job Title: Specialist-Quality Projects

Location: India – Vizag

ROLE SUMMARY:

  • Ability to assess the processes and identify the scope to simplify the processes to make it easy and complying with cGMP requirements.
  • Optimize and simplify the processes all levels of processes and documentation including SOPs, Batch Records etc. across the site.
  • Correct and timely delivery of optimized processes and documentation that comply with GMP and GDP requirements.
  • Ensure end results are designed to mitigate Human Errors and reinforce Data Reliability.
  • End to End project deliverables of the project from scoping of documentation till final approval of the respective documents.
  • To understand end-user requirements e.g. Shop floor employee requirements to execute the processes.
  • Ability to gain insight into the diverse processes in sterile injectable manufacturing and apply this knowledge in the creation of simplified instructions and procedures.
  • Ensuring all documentation delivered as part of the project complies with the PHP methodology, and is written documentation and training principles.
  • Ability to gain insight into the diverse processes in sterile injectable manufacturing and apply this knowledge in the creation of simplified instructions and procedures.
  • Ensuring all documentation delivered as part of the project complies with the PHP methodology, and is written documentation and training principles.
  • Check and ensure that all instructions and procedures of quality systems are in line with the operational work instructions and procedures.
  • Work within the Quality system including usage of Pfizer Document Management system to ensure Quality and Compliance.

Technical Skills:

  • Understanding in Pharmaceutical manufacturing and Quality Operations.
  • Have overview knowledge of sterile manufacturing and testing operations.
  • Process mapping abilities.
  • Knowledge of DMAIC and PHP tools.

Efficient Time-management skills:

    • Correct and timely delivery of optimized processes and documentation.
    • End to End project deliverables of the project from scoping of documentation till final approval of the respective documents.

Efficient Time-management skills:

  • Correct and timely delivery of optimized processes and documentation.
  • End to End project deliverables of the project from scoping of documentation till final approval of the respective documents.

Standards, Processes & Policies:

Knowledge of GMPs and regulations governing manufacturing operations for sterile products including aseptic processing.

Global Pfizer Quality Systems, Good practice bulletins.

Check and ensure that all instructions and procedures of quality systems are in line with the operational work instructions and procedures.

Effective interpersonal skills.

  • Ability to work and influence cross-functional teams.
  • Collaborate with the CFTs to get concurrence on the simplifications.
  • Understand end-user requirements e.g. Shop floor employee requirements for processes execution and provide simplified documentation practices.
    Work within the Quality system to ensure Quality and Compliance.

Preferred Education/ Qualification:

Bachelor’s/ Master’s Degree in Sciences/Pharmaceutical Sciences

Experience:

Minimum 5 years of working experience in the Pharmaceutical industry.

Core Competencies :

  • Optimize and simplify the processes with all levels of documentation
  • Trained in DMAIC and PHP tools.

Behavioral /Other skills:

  • Critical thinker.
  • Persistent approach to problem-solving.
  • Ability to work and influence cross-functional teams.
  • Effective interpersonal skills.
  • Strong communication and presentation skills.
  • Efficient time management skills

Click here to Apply online

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