Associate Manager - MSAT (C&Q)

Biopharma Careers; Visakhapatnam; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Biopharma Careers seeks an experienced QA/Validation professional to evaluate and approve validation master plans, protocols, and reports in line with GMP and Pfizer standards.

You will troubleshoot equipment/process validation issues, perform statistical data analysis for investigations, and guide document creation and approvals across validation activities.

Qualifications

• B. Pharm/ M. Pharm/ B Tech/ BE degree in related field.
• 6-8 years of experience in Quality Assurance / Validation.
• Understanding of pharmaceutical manufacturing, packaging and QA operations.
• Knowledge of validation principles for manufacturing, cleaning, utilities, and CSV.

Responsibilities

• 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.
• Maintain Site Validation Master Plan and support regulatory audits, representing validation on site or network teams.
• Support product transfers, regulatory queries, cost improvement projects, and Cleaning Validation, ensuring integration of validation schedules in production.

Skills

Quality Assurance

Validation

Good Manufacturing Practices

Statistical analysis

Documentation control

Education

B. Pharm/ M. Pharm/ B Tec/ BE

Tools

Global Document Management System

SAP

Quality Tracking System

Job description

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

• 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, including risk 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.