Associate - Validation null

About Pfizer

Pfizer Healthcare India Private Limited (PHIPL) is a legal entity incorporated under the provisions of the Companies Act, of 1956. It is an export-oriented undertaking of Pfizer Inc. They are committed to living their purpose, ‘Breakthroughs That Change Patients’ Lives’. It is grounded in their commitment to fund programs that provide public benefit, advance medical care, and improve patient outcomes. Their belief is, that all people deserve to live healthy lives. This drives the desire to provide access to medicines that are safe, effective, and affordable.

Your role

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

• You will be a member of Pfizer’s dedicated and highly effective quality assurance team.
• You will be responsible for the evaluation, review and approval of the 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 validation process documents and technical reports related to equipment, products and processes.

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

Responsibilities:

• 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 the 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 the development 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 are reviewed by the QO product professional and approved by production and quality management.
• Define problems, collect data, establish facts, and draw a valid conclusion.
• Work in a team environment to meet all team objectives and communicate progress on scheduled projects.

Training, development & rotations

Whether you’re a recent graduate or are at college and looking for a summer placement, discover their range of programs designed to help you learn, develop, and make an impact in a truly world-class company. You can be confident you’ll thrive too, whatever your background. Pfizer is committed to empowering every colleague to create their growth journey to unleash their potential, propel themselves forward, and deliver on their purpose.

• Breakthrough Fellowship Program
• Digital Rotational Program
• MBA Summer Associate Program
• Medical And Pharmacy Student Opportunities
• PGS Rotational Development Program
• PGS Summer Development Program
• Postdoctoral
• R&D Rotational Program
• Pfizer Summer Growth Experience

To learn more about these programs click here

Salary & benefits

The annual salary for this role can range from INR 3.5 Lakhs to INR 4.0 Lakhs (Source: AmbitionBox). They provide the following benefits

• Pay for Performance Philosophy and Practices: Compensation policies
• Benefits to Maintain and Promote Health and Wellness: These programs can include health and disability insurance, preventative health programs, medical screening, free or reduced-cost vaccinations, discounts on Pfizer products, and nutrition and fitness counselling.
• Benefits to Help Colleagues Meet Financial Goals: These programs can include access to colleague-directed retirement funds, company contributions to retirement financial vehicles, life insurance, and financial planning education.
• Breakthrough Benefits for the moments that matter new parents may take at least 12 weeks of paid leave following their child's birth or adoption and may take up to 2 weeks of paid caregiver leave each year to care for family members.

To learn more about the benefits provided by Pfizer click here

Career progression

Pfizer has transformed growth and development to ensure that everyone can follow the path to their dream career, whether that’s climbing a traditional, vertical ladder – or as they like to call it – ‘zig-zagging’ their way to a new role. Growth at Pfizer isn’t linear, success isn’t limited, and advancement opportunities are abundant. Their Growth and Talent Strategy fuels colleague growth promotes internal movement and cultivates a culture of collective talent ownership.

Creating a strong pool of well-rounded leaders is more than just words on paper. They are committed to providing people with the opportunities they need to grow – in many cases, that means fostering non-linear growth.

As a Pfizer colleague, you may focus on being the best in your current role (‘Grow in Role’) and grow your knowledge and develop a stronger foundation in a specific area. You might use your expertise on a new project or in a new role to develop a broader perspective of your function or discipline (‘Next Experience’). You may take a step up to a different part of the business to expand your view of Pfizer (‘Cross-Functional’), or to a position of greater responsibility and challenge (‘Next Level’). How you grow is determined by you.

Work-life balance

Pfizer has a good, inclusive work environment and a diverse working culture, one of the best in the industry. They always take care of their employees and their working lives.

Culture & vibe

Pfizer is a professional, international company with a strong focus on research and development. The company offers a wide range of career opportunities for talented and ambitious employees. Pfizer is committed to inclusion and diversity in the workplace. The company has a range of initiatives in place to support employees from all backgrounds.

About you

To apply for this position:

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 the 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 the 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

How to apply

To apply for this role, just click on the Apply on employer site button. It will navigate to the career section where the application can be submitted.