Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support.
Post : Specialist - Quality Projects
Job Description
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.
• 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.
Candidate Profile
• Bachelor’s/ Master’s Degree in Sciences/Pharmaceutical Sciences
• Minimum 5 years of working experience in Pharmaceutical industry.
• Optimize and simplify the processes with all levels of documentation
• Trained in DMAIC and PHP tools.
• 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.
• 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.
• 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.
• 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 the simplified documentation practices.
• Work within the Quality system to ensure Quality and Compliance.
• 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
Additional Information
Qualification : M.Pharm, B.Pharm, MSc
Location : Vizag
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 28th February, 2021
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