Associate Manager Validations
- Pfizer
- 4 - 7 years
- Visakhapatnam
- 1 month ago
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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
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)
- B Pharma / M Sc. with 5+ 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
Core Competencies :
- Understanding of pharmaceutical manufacturing, packaging, quality assurance, and quality control operations.
- Knowledge of validation principles and practices related to the following areas: manufacturing process, facility, equipment, instrument, utility system, and CSV systems.
- Conversant with design & working principles of key equipment used in sterile manufacturing -autoclave, tunnel, homogenizers, Vial filling, filter integrity testing devices.
- Experience in handling internal Audit at site.
- Experience in plant and TS operations.
- Good document review and approval skills, with ability to identify issues, investigations and recommend actions.
- Deviations handling and Investigations skills.
- CCF handling and assessment skills.
- cGMP and application of quality management systems.
- Good documentation practices-cGDP.
- Technical writing and document review and Approval skills.
- Ability to review and Approve standard operation procedures and related validations.
- Knowledge of current validation regulations in the industry.
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Customer Success, Service & Operations,
Role Category: Operations
Role: Operations - Other
Employement Type: Full time
Contact Details:
Company: PfizerLocation(s): Visakhapatnam
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Keyskills: Medical devices Data analysis Manager Quality Assurance Manufacturing process Technical writing Pharma Analytical Quality systems Packaging Manager Quality Control
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