Quality Operations Lead (Head) | Vizag | Pfizer

Job Description

Responsible for leading Quality Operations and related aspects for the site with the following key responsibilities

• Quality oversight for Manufacturing and Packaging QA, Incoming Quality, Engineering QA, QC
• Laboratories, Investigations QA, and Validation operations QA.
• Implementation of global quality policies, and procedures and ensuring their compliance
• Monitor quality indicators for operations and ensure controls are in place & maintained for cGM activities.
• Monitor Manufacturing and Packing activities to ensure compliance with the systems and procedures as per cGMP. e Responsible for trending of quality indicators in manufacturing operations.
• Provides technical, quality oversight and support to the SQOL in making quality decisions on corporate hold, High-Risk Deviations from the manufacturing/packaging areas quality-driven metrics.
• Ensures all investigations are appropriately investigated prior to batch release A system for batch release is developed and executed as a part of routine commercial operations. Mentor the team in current expectations of production and process controls to make quality decisions
• upstream of the process to mitigate downstream risk.
• Partnership with operations team for driving best practices.

Role & Responsibilities:

Complexity and Scope of Responsibility

Sets objectives for and manages multiple projects/ ongoing work activities of moderate complexity within Sub Business Unit/Sub Operating Unit​

​​Resource Utilization

• Manages and leads people, technological and financial resources at the Sub Business
• May lead by influence rather than direct authority​​

​​​Breadth and Depth of Knowledge

• Provides technical/functional leadership to teams
• Leverages technical/functional expertise across own and related disciplines.
• Demonstrates comprehensive industry knowledge.
• Exhibits business expertise and an understanding of the external marketplace and customer requirements.​

​Knowledge Sharing

• Actively shares knowledge with others across multiple Sub Business units/Sub Operating units through existing knowledge-sharing processes/systems
• Encourages others to share knowledge across the organization.​

Innovation and Risk-Taking

• Identifies existing process/product improvements
• Develops innovative, advanced new concepts that improve processes/products across own and related disciplines
• Takes appropriate risks to achieve desired results​​

​The complexity of Decisions (e.g., Ambiguity, Complexity of Solutions)

• Solves complex problems, where previous experience outside of own area may be relevant.​

Impact of Decisions

• Decisions impact multiple Sub Business Unit/Sub Operating Units’ mid-term objectives
• Significant or long-term decisions are reviewed by senior management​

​Vision, Strategy, and Business Alignment

Establishes operational activities/projects that support mid-term goals and set the direction for the Sub Business Unit/Sub Operating Unit.​

​People Management

• Recognizes development needs and identifies/creates development opportunities (e.g., special assignments) for colleagues within own Sub Business Unit/Sub Operating Unit
• Develops a talent base and anticipates development needs within the area of responsibility.
• Manages performance of direct and indirect reports and supports Sub Business Unit/Sub Operating Unit objectives through goal setting, ongoing assessment and coaching, and performance evaluation.

​Communication

• Uses communication to help ensure alignment within and outside of Sub Business Unit/Sub Operating Unit​
• Creates and delivers presentations to direct reports and other internal stakeholders across Sub Business Unit/Sub Operating Unit.​

​Influencing Others

• Manages teams that execute direction for the Sub Business Unit/Sub Operating Unit
• Provides input to senior management decisions that may have an impact on business direction within the Sub Business Unit/Sub Operating Unit
• Partners with Global Business Unit/Global Operating Unit or Sub Business Unit/Sub Operating Unit leadership to accomplish objectives.​

​Managing Change

Prepares for and manages change that impacts the Sub Business Unit/Sub Operating Unit.​

QUALIFICATIONS: Graduation or Post Graduation in Pharmacy or Science with 15+ years of experience in Quality Assurance or Quality Control, Preferably sterile dosage form facility.