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 be responsible for evaluation, review and approval of validation master plan, protocols and reports. Your methodological approach will help us ensure compliance of our quality systems with company standards and government regulatory requirements. Your
problem-solving ability will help us troubleshoot validation problems for equipment and performance processes and conduct statistical analysis of testing results and process anomalies. Your documentation skills will guide the writing, review and approval of for validation process documents and technical reports related to equipment, products and processes.

As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues.

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

How You Will Achieve It

• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Determine process capability of new equipment through execution of approved protocols and assure defined parameters are incorporated into respective operating procedures and batch records.
• Assists with development of validation protocols and manage Regulatory queries and responses.
• Participate in deviation investigations to identify root causes and define corrective and/or preventative actions.
• Adhere to all company and Good Manufacturing Practices {also cGMP} procedures, along with safety regulations within the plant and participates in developments of validation programs as needed to remain current with cGMPs and industry.
• Work effectively as a member of the Quality Operations (QO) Good Manufacturing Practices {also cGMP} training team as well as directly with Business Area Training Leads / Coordinators and SMEs within Quality to support Good Manufacturing Practices {also cGMP} and site training initiatives.
• Report to the Validation Section Manager, the Validation Engineer will assure that equipment, facilities, and utilities are validated in accordance with {Current} Good Manufacturing Practices {part of GxP} principles, regulatory requirements, and company policies and standards.
• Work on summarization of data into concise reports that is reviewed by the QO product professional and approved by production and quality management.
• Define problems, collect data, establish facts, and draw valid conclusion.
• Work in a team environment to meet all team objectives and communicate progress on scheduled projects.

Qualifications

Must-Have

• B.Pharm/ M.Pharm/M.S (Pharmacy)/M.Sc/BE
• Experience : 0-3 years.
• Understanding of pharmaceutical manufacturing, packaging, quality assurance, and quality control operations.
• Knowledge of validation principles and practices related to the following areas: manufacturing process, analytical method, cleaning methods, facility, equipment, instrument, utility system, and CSV systems.
• Conversant with design & working principles of key equipment used in sterile manufacturing –autoclave, tunnel, lyophilizers, homogenisers, filling machine, filter integrity testing devices.
• Well versed with Terminal process – design, execution and review.
• Experience in plant and QC lab operations
• Good document written skills, with ability to identify issues and recommend actions.
• Knowledge of current validation regulations in the industry.
• cGMPs and FDA , MHRA, TGA, MCC etc. regulatory guidelines and validation principles.
• Excellent attention to detail and working knowledge of Food and Drug Administration Regulations/Guidance, and Good Manufacturing Practices
• Excellent organizational skills, and ability to handle changing deadlines
• Strong communication with written and verbal skills
• Working knowledge of Microsoft Office, especially Excel for evaluation of data

Nice-to-Have

• Technical writing experience
• Pharmaceutical Industry with laboratory process validation experience
• Working knowledge of equipment qualification and calibration specifically for laboratory equipment

 
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.

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