Associate - MSAT (C&Q)

Use Your Power for Purpose

Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our flexible, innovative, and customer-oriented quality culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a meaningful difference in the lives of those we serve. Join us in our mission to improve patient outcomes through excellence in every aspect of our work.

What You Will Achieve

In this role, you will:

• Evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with regulatory requirements and company policies.

• Troubleshoot validation problems for equipment and performance processes, conducting statistical analysis of testing results to address process anomalies.

• Write, review, and approve validation process documents and technical reports related to equipment, products, and processes.

• Contribute to project tasks and milestones, organizing work to meet deadlines and applying basic team effectiveness skills within the immediate Work Team.

• Make decisions within limited options to resolve basic problems, working under the supervisor's direction and seeking guidance from colleagues.

• Ensure work is regularly reviewed for technical judgment, completeness, and accuracy, exercising judgment with reliance on the supervisor.

• Determine the process capability of new equipment through the execution of approved protocols, incorporating defined parameters into operating procedures and batch records.

• Assist with the development of validation protocols, manage regulatory queries and responses, and participate in deviation investigations to identify root causes and define corrective and preventative actions.

• Adhere to all company and Good Manufacturing Practices (cGMP) procedures, safety regulations, and participate in the development of validation programs to stay current with cGMPs and industry standards.

• Work effectively as a member of the Quality Operations (QO) cGMP training team, collaborating with Business Area Training Leads, Coordinators, and SMEs to support cGMP and site training initiatives, reporting to the Validation Section Manager and summarizing data into concise reports for review and approval.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with any years of experience, or  an Associate's degree with 4 years of relevant experience, or a high school diploma (or equivalent) and 6 years of relevant experience

• Excellent attention to detail and a solid understanding of Food and Drug Administration Regulations/Guidance and Good Manufacturing Practices

• Strong organizational skills and the ability to manage changing deadlines

• Proficiency in Microsoft Office, particularly Excel, for data evaluation

• Strong written and verbal communication skills

• Ability to work in a team environment and collaborate effectively with colleagues

• Basic understanding of validation principles and practices

Bonus Points If You Have (Preferred Requirements)

• Technical writing experience, particularly within the pharmaceutical industry

• Laboratory process validation expertise

• Working knowledge of equipment qualification and calibration, especially for laboratory equipment

• Experience with regulatory queries and responses

• Excellent interpersonal skills and the ability to work collaboratively with cross-functional teams

• Adaptability and flexibility in a dynamic work environment

• Commitment to continuous learning and professional development

• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

Essential Requirements:

• Preferred Education/ Qualification: B.Pharm / M.Pharm / M.S (Pharmacy)/ M.Sc / BE / BTec

• Experience: 2-3 years of experience in Quality assurance and / Validation function of sterile dosage form facility / Formulation Development/ Product Development/ Process Development/ Technology Transfer/ Production of Injectable formulations to cater regulated market, essentially experience in Plant Technology Transfer support in Injections.

• Understanding of pharmaceutical manufacturing, packaging, Quality assurance, and Quality control operations.

• Knowledge of validation principles and practices related to the following areas: manufacturing process, cleaning methods, facility, equipment, instrument, utility system, and CSV systems.

• Conversant with design & working principles of key equipment used in sterile manufacturing –autoclave, vial washing, heat tunnel, homogenizers, filling machines , filter integrity testing devices, visual inspection equipment, packing equipment, and, cleaning Validations.

• Execute validation protocols of manufacturing equipment, visual inspection equipment, packing equipment, Utilities and Cleaning Validation in accordance with regulatory requirements, cGMPs, corporate policies and procedures and as per schedule.

• Operation and Calibration of Validators and qualification accessories.

• Preparation, participation and review of qualification documents (i.e. IQ / OQ/ PQ protocols, etc.) and Reports.

• Coordinate and plan qualification/Validation activities with Manufacturing, engineering and with other cross functional teams.

• Performs Data analysis, Investigation of Validation deviations for the root cause identification. 

• Compile validation documents and results.

• Execution/ oversite of executions and reporting of deviations.

• Perform Risk assessment to establish the scope and extent of validation activities.

• Good document written skills, with ability to identify issues and recommend actions.

• Knowledge of current validation regulations in the industry and validation principles.

• cGMP, FDA, MHRA and TGA, etc. regulatory guidelines.

• Awareness of safety at working place

 
 

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