Job Description

Pfizer Singapore is recruiting permanent employees for manufacturing site expansion of PFIZER ASIA MANUFACTURING PTE LTD (PAMPL) in Singapore.

Why Patients Need You

Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you\'ll help bring medicines to the world even faster by imagining what\xe2\x80\x99s possible and taking action.

What You Will Achieve

Working with Pfizer\xe2\x80\x99s dynamic engineering team, you will play a critical role in design and development of manufacturing process to bring products from research to manufacturing. You will leverage your technical capabilities to understand the inherent problems related to transfer of technology from the research stage to manufacturing, in cooperation with pilot-plant and production departments. You will conduct tests and measurements throughout the stages of production and troubleshoot production process problems with processes or equipment already in operation.

As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will make it easy to manage difficult issues and help in establishing consensus between teams.

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

POSITION SUMMARY

Summarize the primary purpose & key accountabilities of the position, including scope of responsibility in 5-7 concise sentences (i.e. Global vs. Country/Region).

The incumbent is member of the Quality Control (QC) Laboratory team. Under the supervision of the Senior QC Manager, the incumbent will be responsible for the operational aspects of all analytical testing within the QC Laboratory. Key accountabilities include:

• Lead, coach and develop the QC personnel (analysts, chemists and/or microbiologists) to ensuring that analytical testing (chemical, physical and/or microbiological) and data review is performed in a safe and reliable manner to support manufacturing operations across all shifts with adherence to site Standard Operating Procedures (SOPs).
• Ensure that the quality systems and practices in the laboratory comply with Good Laboratory Practices (GLPs), Good Documentation Practices (GDPs), current Good Manufacturing Practices (cGMPs) and Pfizer Quality Standards (PQS).
• Deploy and use Imex "way of working" for day to day operations, problem solving, escalation and continuous improvements.

POSITION RESPONSIBILITIES

In order of importance, list the primary responsibilities critical to the performance of the position. Indicate the technical skills required and/or preferred, where applicable. It is recommended not to list actual tasks but focus on essential responsibilities that highlight accountability and level of judgment required.

Responsibilities

• Develop, review and/or approve working procedures for the laboratory.
• Review analytical test results (e.g. product and raw materials)
• Conduct, review or approve laboratory investigations and ensure all follow up actions are completed. Make decisions based on scientific and logical reasoning on behalf of the Senior QC manager when required.
• Supervise QC personnel in operational aspects of performing testing, e.g. troubleshooting laboratory equipment failure and laboratory investigation..
• Train fellow colleagues on written procedures pertaining to equipment operation, test methods and general laboratory operation.
• Conduct training to increase staff knowledge and understanding of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) requirements, product chemistry and sophisticated laboratory equipment.
• Lead or participate in site teams/projects e.g. NPI, continuous improvement, safety-related initiatives.
• Supervise the team of analysts, chemists and/or microbiologists to ensure that DI and ALCOA principles are adhered to.
• Ensure a safe working environment for the laboratory. Lead initiatives to improve safety performance and colleague engagement. Perform investigation related to EHS (as needed).
• Work closely with QA, Production, Technical Services, Engineering and EHS personnel to support them in laboratory testing and trouble-shooting when required.
• Help to manage the budget of the laboratory expenses.
• Develop the skills and capabilities of QC analysts, chemists and/or microbiologists.
• Play an active and impactful role in Tier processes by updating performance against metrics, highlighting & resolving issues, with appropriate escalations. Develop courses of action and drive implementation of solutions.
• Uphold Pfizer\'s code of conduct and values.
• Collaborate with cross-functional teams to drive flawless execution.
• Stand in for the Senior QC Manager in his/her absence.
• Fulfil requirements of a first line leader (FLL) as described in site procedure that includes (but is not limited to) the below:

• Engage and inspire team on performance expectations and coach the team to meet expectations using Coaching Skills principles
• Effectively monitor the actions of team members. Ensure presence in the GMP work area to observe work activity and practices.
• Be available for direct report(s) for real time escalation of any concerns or support needs
• Be accountable for Good Data Management and Data Integrity understanding and performance of the team
• Be a role model to support a positive compliance culture
• Be vigilant for potential actions or behaviour that could result in breaches of GMP compliance or Data Integrity principles

Job Related Requirements:

• Effective problem solving skills.
• Demonstrated leadership, innovative and strategic thinking ability and customer service skills.
• Excellent verbal, written communication and presentation skills.
• Demonstrated ability to lead a team in QC testing environment and interact effectively with all levels within the organizations.
• Comprehensive knowledge of cGMPs, GLPs and data integrity requirements for Quality Control laboratories.
• Comprehensive knowledge of LIMS, HPLC, GC and laboratory equipment.
• Experience in Empower software/ SAP will be an added advantage.
• Knowledge of six sigma, lean labs and standard work practices.
• Ability to collaborate with cross functional teams to understand their expectations while ensuring compliance to quality systems and processes.
• Possess a can-do / pride to succeed attitude and be a positive influencer/role model.
• Embrace the use of digital technology to scale and speed up every form of interaction and action.

ORGANIZATIONAL RELATIONSHIPS

Provide the primary groups or key positions that this position will have interaction with as a regular part of the position responsibilities. Include any external interactions as appropriate.

The incumbent will interact with all site departments for GMP related laboratory operations and activities e.g. Manufacturing Operations Process Teams, Quality Assurance, Supply Chain, Engineering, New Production Introduction and Technical Services teams as well as above site teams (e.g. PQS SMEs). In the event of quality or regulatory related issues, this position will interact with quality or regulatory representatives from drug product sites or Global Chemistry Manufacturing & Compliance (GCMC) teams as required in conjunction with the QA Manager.

For instrument / equipment and laboratory supplies-related matters, this position will interact with vendors.

RESOURCES MANAGED

Indicate the Average Budget or Revenue accountability, where applicable. If not applicable, indicate NA. Indicate the typical number of Colleagues managed. Include direct & indirect reports, matrix responsibility and or additional resources (i.e. contingent workers), where applicable. If not applicable, indicate NA.

Financial Accountability

N/A

Supervision

The incumbent is responsible for 8-12 direct reports.

EDUCATION

Indicate the formal education, certification or license required and/or preferred.

Bachelor or Master or Ph.D degree in Science (Chemistry preferred) or Life Science relating to Chemistry, Pharmacy, Pharmacutical Science or Microbiology or a related science.

EXPERIENCE

Include the minimum number of years of relevant experience required for the position (where legally permissible).

• Minimum 8 years of technical experience in Quality Control within the pharmaceutical, food, chemical or process industries. Additional experience in Quality Assurance is highly desirable.
• Experience in managing/supervising large (8-12) groups of laboratory analysts, chemists and/or microbiologists.
• Successful track record of continuous improvement, development and/or implementation of best practices in Quality Control Laboratories.
• Effectively communicate through written and oral means, demonstrated ability to interact effectively with senior management, auditors and regulators.

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

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Pfizer