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’s dedicated and highly effective quality assurance team. You will evaluate and review Pfizer’s clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

As a Team lead, you will be involved in leading work teams. You will lead the people, technical and financial resources of the team. Thanks to your technical skills, you will coach your direct reports on day to day activities. You will be relied on to solve complex problems within your area of expertise.

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

Position Responsibilities

• Write, approve and review working procedures for the QA.

• Manage the manufacturing support, cleaning and batch release, new product introduction activities and compliance/regulatory request.

• Plan and control manufacturing support and supply requirement.

• Able to make decisions based on scientific and logical reasoning on behalf of the QA Manager when required.

• Supervise QA personnel in manufacturing support end to end activities.

• Conduct training to increase s knowledge and understanding of regulatory requirements, PQS, Good Manufacturing Practices (GMP) requirements and ALCOA.

• Participate and lead site teams/projects e.g. Safety, continuous improvement, manufacturing support and QA Oversight

• Work closely with Quality Operation, Production, Engineering, Warehouse and Supply chain personnel to support them in QA oversight, supply demand planning and system troubleshooting when required.

• Update and optimize QA resources and capacity utilization · Develop the skills and capabilities of QA Specialists.

• Stand in for the QA Manager in his/her absence. Front Line Leader responsibilities: · Engage and inspire the teams on performance expectations and coach the team to meet those expectations using Coaching Skill principles.

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

• Know the processes and procedures, including the principles and practices of good data management (ALCOA), and be able to guide, advise and coach the teams.

• Be accountable for the Good Data Management and Data integrity understanding and performance of the team.

• Effectively monitor the actions of the team. Ensure an active daily presence in the GMP work area to observe the work activity and practices within their role responsibilities. 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. · Be observant, investigate and report actions or behaviors that may negatively impact the desired outcome of the GMP process or activity.

• Lead and support continuous improvement efforts, where applicable.

• Be a role model to support a positive compliance culture.

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

Accountable for:

• Batch book review and Batch release (API and Intermediates)

• Equipment Cleaning release, IBC release

• Production Support (Pre MI/Post MI)

• Plant cleaning strategy and validation

• CI Projects KPI’s include:

• SLA for Batch release performance

• Manufacturing attainment

• APRR schedule adherence

• Compliance to cGMP/cGLP/cGAMP requirements

Qualifications

Must-Have

• Minimum 6 years of directly related experience in pharmaceutical manufacturing and quality operations, or equivalent combination of work experienceand education.

• Minimum 2 years in a supervisory capacity.

• Experience in an API manufacturing plant is preferred.

• Related experience different pharmaceutical manufacturing facilities is also preferred.

Job Related Requirements:

• Demonstrated record of successful interaction with global regulatory agencies (e.g., FDA, HSA, MHRA) and other internal and external auditing groups.

• Successful track record of continuous improvement, development, and/or implementation of best practices in quality operations or manufacturing.

• Thorough knowledge and understanding cGMP, GAMP, validation principles, and applicable regulations related to validation principles.

• Excellent verbal, written and interpersonal communication skills.

• 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.