Quality Operations Lead (Head) | Vizag | Pfizer

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Job Overview

  • Date Posted
    25/08/2022
  • Location (State / UT)
  • Expiration date
    --
  • Experience
    15 Years
  • Gender
    Any
  • Desired Qualification
    Bachelor Degree, Master’s Degree
  • Salary in (₹)
    Negotiable

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.