Job Description

Why Patients Need You

Everything 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 Achieve

You will be a member of Pfizer\xe2\x80\x99s dedicated and highly effective quality assurance and control team. You will be responsible for analyzing chemical, biological or microbiological products to support our quality programs. Your contribution to environmental testing, utility monitoring, analytical testing, microbial identification and sterility testing will help Pfizer provide safe drugs to patients.

Your understanding of Quality Control (QC) instruments will help us meet their accuracy specifications against established standards. You will also be relied on for setting requirements for the transfer of methodology from Research and Development (R&D).

As a Manager, your breadth of knowledge on internal or external business challenges will help us improve our products, processes and services. Your will guide us to lead projects by meeting objectives and preparing forecasts for resource requirements. Your risk-taking ability will help us advance new concepts and methodologies. You will provide technical guidance and oversight to team members and help in problem solving.

It is your dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

Planning and execution of all Qualification related activities.

Handling of internal and external audits.

Support for on time closure of Incidents / CAPA / CCF.

Ensuring the Personnel safety in the Quality Control, Safe handling of Laboratory Glassware.

Providing impact assessment for cross functional Change controls.

Qualifications

Planning and execution of all Qualification related activities.

Handling of internal and external audits.

Support for on time closure of Incidents / CAPA / CCF.

Ensuring the Personnel safety in the Quality Control, Safe handling of Laboratory Glassware.

Providing impact assessment for cross functional Change controls.

Evaluate the PQS changes applicability to site procedures and requirement of CAS report preparation.

Planning and execution of all Qualification related activities.

Handling of internal and external audits.

Support for on time closure of Incidents / CAPA / CCF.

Ensuring the Personnel safety in the Quality Control, Safe handling of Laboratory Glassware.

Providing impact assessment for cross functional Change controls.

Implementation of Electronic documentation and Electronic signatures in analytical systems.

Maintaining of all Equipment Qualification documentation in PDOCS as applicable in conforms to the Good documentation practices.

Demonstration of the systematic approach of the impact assessments and Quality risk management of the Equipment\xe2\x80\x99s or Systems.

Support to the system users on operation of Equipment/process throughout the life cycle.

Escalation of analytical issues to next level.

People Management:

\xc2\xa7 Engage and inspire the team on performance expectations and coach the team to meet those expectations using Coaching Skill principles.

\xc2\xa7 Focus on Safety and GMP Compliance as operational priorities and as performance measures that should be included in metrics.

\xc2\xa7 Know the processes and procedures, including the principles and practices of good data management (ALCOA), and be able to guide, advise and coach the team.

\xc2\xa7 Be accountable for the Good Data Management and Data integrity understanding and performance of the team.

\xc2\xa7 Effectively monitor the actions of the team. Ensure an active daily presence in the GMP work area to observe the work activity and practices.

\xc2\xa7 Note: any compliance deviations noted must be investigated in accordance with Site Standard Operating Procedures. Be available to the direct reports for real time escalations of any concerns or support needs

\xc2\xa7 Be observant, investigate and report actions or behaviors that may negatively impact the desired outcome of the GMP process or activity.

\xc2\xa7 Lead and support continuous improvement efforts, where applicable.

\xc2\xa7 Be a role model to support a positive compliance culture.

\xc2\xa7 Review the content of all Leader Led Conversations and, on an annual basis, conduct two \xe2\x80\x98Leader Led Conversations\xe2\x80\x99 with the teams aimed at fostering a culture that supports compliance with procedures, including good data management.

Be vigilant for potential actions or behaviors that could result in breaches of GMP compliance or Data Integrity principles.

Must-Have

• Bachelor\xe2\x80\x99s/ master\xe2\x80\x99s degree in pharmacy/ sciences \xe2\x80\x8b
• 10+ years of relevant pharmaceutical industry experience
• Demonstrated experience in Quality Control
• Extensive knowledge of Good Manufacturing Practices {also cGMP} compliance requirements for Quality Control Laboratories, application of compendial methods and experience with a wide range of analytical techniques
• In-depth understanding of aseptic processing and monitoring procedures
• Reasoning ability including strong analytical and problem-solving abilities.
• Strong people management experience
• Strong verbal and written communication skills

Nice-to-Have

• Master\'s degree
• Knowledge in the application of statistical tools, root cause analysis and/or six sigma methodologies.

Work Location Assignment: On Premise

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

Pfizer