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 

In this position, you will be joining our Quality Operations department which performs critical Quality Control activities. Through collaboration with supporting Quality Control (QC) Laboratory and Manufacturing teams, you will be part of a team which is responsible for providing oversight on analytical technology transfer activities (both into and out of the site). Your work will help the department to build the capabilities and systems to run a more robust Laboratory operation including the organization of long range manpower forecast and finite planning around department specific and routine QC Laboratory operations. 
 

As a Senior Leader you will be setting the objectives for multiple projects in your division. Your managerial and technical skills will help in guiding the people in your division. Your understanding of the external marketplace and customer requirements will facilitate in instituting knowledge sharing practices in your team and outside. You shall be relied on to manage operational activities that support the goals of the division and sets direction for its success. 
 

Through your expertise and extensive knowledge, you will be able to foster a culture that promotes innovation and thrives on doing better for patients and healthcare.  

How You Will Achieve It  

• Set objectives for and manage multiple projects/ ongoing work activities within Operating Unit. 

• Provide support as needed to Quality Operations, Production and Engineering to assess product and process aseptic issues. 

• Participate in internal and external quality assurance assessments and in the assessments of contract operations that supply drug products to Pfizer locations if required. 

• Ensure the timely release of raw materials, in-process, final product materials and stability samples to support operations and compliance with the respective licensed specifications. 

• Ensure standardized Quality Control (QC) practices and systems across all QC functional areas and drive the implementation of Operational Excellence best practices and tools in support of an efficient QC operation. ​

• Develop analytical methods as required to support current and new product introductions, including the creation and validation of analytical methods for cleaning validation activities. 

• Develop and manage the operating budget and capital expenditure proposals for the laboratory to ensure achievement of operational targets. 

• Ensure a safe working environment for the laboratory. Lead initiatives to improve safety performance and colleague engagement. 

• Support continuous process performance evaluation and continuous process improvement for highest effective and efficient process operations. 

• Manage, develop and motivate staff to help realize their maximum potential to contribute towards achieving the site objectives.

•  Ensure the delivery of an excellent customer service to all internal and external customers of the quality control department.  

• Experience in Empower software. 

• Strong and thorough knowledge and understanding of GMP, GLP. 

• Comprehensive knowledge of LIMS, HPLC, GC and laboratory equipment. 

Qualifications  

Must-Have 

• Bachelor’s / Master's Degree and 18+ years of work experience in Pharma only, ​

• Must to have Regulatory Audit Experience, US FDA , Canada, TGA / EU

• Strong knowledge of analytical chemistry, instrumentation, laboratory automation and production processes. 

• Formulation units and Work experience in Injectables facility is must and this should be most recent experience and minimally for a period of 5 years.

• People Management experience. 

• Excellent verbal, written and interpersonal communication and presentation skills. 

Key Skills:

• Manages multiple projects/ ongoing work activities of moderate to complex within the chemistry department typically involving cross-functional representatives.

• Ensure the laboratory Quality/Safety/cGMP/ cGLP procedures

• Ensure adequate facilities, Instruments, Trained Personnel, approved 'procedures for testing of Raw materials, Packaging.

• Very good understanding of QC instruments / equipment’s and current technologies, including qualification, operations and trouble shooting.

• Thorough understanding of current lab digital solutions such as SAP / gLIMS / LIMS any other equivalent systems.

• Very good understanding of 21 CFR requirements for CQ equipment for Electronic Records and Electronic Systems assessment and audit trails.

• Sound and Scientific knowledge on QC process, including testing and Good laboratory Practices.

• Ensure Good Documentation Practices as per ALCOA principles and requirements of DI.

• Understanding of cGMP, GDP and GLP concepts of Pharmaceutical Industry.

• Through with current pharmacopeia requirements and updates and ensuring that the lab is ready for these new challenges.

• Ensure the laboratory metrics are defined, adhered and monitored

Nice-to-Have 

• Knowledge of six sigma, lean labs and standard work practices. 

• Experience leading people leaders and directing a large, complex organization.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.