Website:
bioksha.in
Job details:
Use Your Power for Purpose
Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our innovative, flexible, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care.
What You Will Achieve
In this role, you will:
- Evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with company standards and regulatory requirements.
- Troubleshoot validation issues for equipment and performance processes, providing expertise for resolution.
- Conduct statistical analysis of testing results and process anomalies and provide high-level data analysis support for Quality Investigations.
- Guide the writing, review, and approval of validation process documents and technical reports, ensuring adherence to the latest Pfizer Quality Standards.
- Contribute to moderately complex projects, manage time effectively, and develop plans for short-term work activities.
- Manage routine Quality systems such as Change Control, Quality Agreement, Documentation, and Investigations, and coordinate testing with functional groups.
- Maintain the Site Validation Master Plan, support regulatory audits, and represent engineering validation on site or network teams.
- Support product transfers, new product development, regulatory queries, cost improvement projects, and Cleaning Validation, ensuring integration of validation schedules in production and participating in deviation investigations.
Here Is What You Need (Minimum Requirements)
- High school diploma (or equivalent) with 8+ years of experience or associate’s degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience
- Proven expertise in Good Manufacturing Practices
- Strong working knowledge of various quality systems and processes
- Familiarity with information systems such as Global Document Management System, System Application & Products, and Quality Tracking System
- Excellent verbal and written communication skills
- Ability to work independently and in a team environment
Bonus Points If You Have (Preferred Requirements)
- Strong technical knowledge with validation/qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems
- Experience with sterile products and medical devices
- Strong analytical and problem-solving skills
- Strong organizational and time management skills
- Ability to mentor and guide other colleagues
- Experience in regulatory audits and compliance
- 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, includingrisk management and ethical use
Essential Requirements
- Preferred Education/ Qualification:B. Pharm/ M. Pharm/ B Tec/ BE
- Experience: 6-8 years of experience in Quality Assurance / Validation function / Engineering of sterile dosage form facility / Production of Injectable formulations to cater regulated market.
- Understanding of pharmaceutical manufacturing, packaging and quality assurance operations.
- Knowledge of validation principles and practices related to the following areas: manufacturing process, cleaning methods, facility, equipment, utility system, and CSV systems.
- Conversant with design & working principles of key equipment used in sterile manufacturing –Autoclave, Vial washing, Depyrogenation tunnel, Vail filling, stoppering and sealing, Solution preparation, Filter integrity testing devices, Visual inspection equipment, Packing equipment, and Cleaning Validations.
- Compile validation documents and results.
- Develop facility qualification reports.
- Knowledge on the Validation concepts and ability to train the people.
- Preparation of the traceability matrix.
- Review of DQ, FAT/SAT activities/documents Preparation, participation and review of qualification documents (i.e. IQ / OQ/ PQ protocols, etc.) and Reports.
- Preparation and execution of spread sheet qualification protocols.
- Ensure revalidations are performed within the established intervals.
- Coordination of validation execution with CFT.
- Performing Alarm assessment during qualification.
- Performs Data analysis and review.
- Review and investigation of qualification deviations.
- Execution and review of IQ/OQ/PQ protocols and Reports.
- Problem Solving: Ability to investigate, identify root cause and preventative measure using DMAIC tool and other appropriate tools.
- Experience in plant and TS operations.
- Good document review skills, data analysis with ability to identify issues and recommend actions
- Knowledge on the Qualification instruments and Tools.
- Knowledge on the GAMP requirements, PDA guidance, ISO guideline, 21 CFR part 11.
- Knowledge on the Components level assessment, PM requirement.
- Good knowledge on the Validation instruments calibration.
- Knowledge on the assessment of the Change controls and failure investigations.
- cGMPs and FDA 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.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available onPfizer Careers.
Quality Assurance and Control
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