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, procedures and ensure 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 to 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.

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.
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 Unit/Sub Operating Unit 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
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 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 support 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.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control
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