Job Description

ROLE SUMMARY
Responsibilities include direction and leadership for Terminal Sterilization Block manufacturing process operations and compliance, training, documentation and develop policies and procedures to ensure quality, safety as well as production targets within budgeted guidelines
ROLE RESPONSIBILITIES
Managerial Responsibilities:
Breadth and Depth of Knowledge

• Provides technical leadership to teams
• Leverages technical 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 suites / areas 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

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

Vision, Strategy and Business Alignment

• Establishes operational activities/projects that support mid-term organization goals and set direction for the teams

People Management

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

Communication

• Uses communication to help ensure alignment within and outside of your own functional area.
• Creates and delivers presentations to direct reports and other internal stakeholders

Influencing Others

• Manages teams that execute direction
• Provides input to senior management decisions that may have an impact on business direction.
• 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 site performance.

Technical Responsibilities:

• Review new concepts, communicate with vendors for new requirements
• Review and approval of URS for new equipment’s

Qualification

• Execute FAT activity applicable to the new equipment
• Review and approve executed SAT, IQ, OQ, PQ protocols and Process Validation and Performance Verification documents
• Ensure implementation of Performance Verification schedule

Operation

• Review the production schedule in consultation with PPIC and functional head.
• Ensure smooth operation, cleaning and maintenance in Suite-1 area
• Manage change parts as per requirement
• Identification of new change parts
• Ensure the unavailability of materials required for smooth uninterrupted operations of equipment and optimization of energy utilization
• Approve the indent for the required materials
• Deploy manpower optimally and conduct/ensure the on-job training for newly joined employees
• Attend product quality review meetings
• Participate in the cross functional department meetings as and when required.
• Provide inputs for department budget
• Being responsible for the selection and maintenance of equipment
• Monitoring product standards and implementing quality-control programs
• Liaising among different departments
• Ensuring that health and safety guidelines are followed
• Supervising and motivating team members
• Reviewing performance of the team members periodically
• Identification of training needs
• Ensure compliance with workplace safety programs.
• Train the teams for maximum Suite-1 area flexibility
• To ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need
• To ensure that the appropriate validations are done
• To ensure the qualification and maintenance of his department, premises and equipmentTrain the teams for maximum production flexibility

Quality Management and Compliance

• Implement cGMP and ensure compliance with laid down SOPs, Quality Systems, Safety Systems and Pfizer policies at all stages of activity
• Participate in regulatory inspections for advanced markets (both internal and external)
• Support development of responses to market complaints and implement corrective actions
• Support investigation, identify root causes and suggest CAPA
• Review and approval of change control
• Review, approval and finalization of deviations

Recruitment and Training

• Plan manpower requirements for near and long term
• Support Human Resources function in recruitment and onboarding
• Conduct/ensure the on-job training for new hires
• Identify training needs on an ongoing basis

Documentation

• Review & prepare MIS report of the process area
• Review of global and site Change Control forms to analyze the impact of change in Product quality, existing systems and procedures.
• Review of CAPA & effectiveness verification reports, trend reports, investigation reports, logbooks and its compliance.
• Ensure the production procedures are in line with the PQS requirement as per the Pfizer global policies.
• Prepare/review the written procedures
• Reviewing current guidelines and suggesting necessary up gradations to the existing Procedures.
• Review of logbooks and its compliance
• Ensure training completion

Continuous Improvement

• Partner with cross functional departments to identify continuous improvement initiatives (process improvement, energy efficiency, etc.)
• Ensure implementation of identified initiatives like TPM, IMEX, OEE

Cultural Attributes
All Pfizer colleagues are expected to conduct themselves in line with the Pfizer Values; Courage, Equity, Excellence & Joy
Statutory Obligations
All colleagues are expected to conduct themselves in line with relevant legislation pertaining to workplace health and safety, discrimination, harassment and bullying.
Environmental Health and Safety
Participate in and take responsibility for workplace environment, health and safety at the level required for this position, following the guidelines in the company Environmental, Health and Safety Management System Manual.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Manufacturing
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