Pfizer Site Validation Lead in Vizag, India
16+ years of experience in quality assurance and /or validation function of sterile dosage form manufacturing facility
Validation & Qualification
Accountable for activities involved in the evaluation, review and approval of the validation master plan, validation protocols and reports and typically includes developing and evaluating quality process and system standards to ensure compliance with company standards and governmental regulatory requirements, investigating/troubleshooting validation problems for equipment and/or performance processes, conducting statistical analyses of testing results and process anomalies, and writing, reviewing, approving and/or implementing documentation for new and current validation procedures and technical reports related to equipment, products and/or processes
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
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.
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.
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.
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.
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.
- 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.