Why Patients Need You
Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.
What You Will Achieve
You will co-ordinate the manufacture of key API (Active Pharmaceutical Ingredients) Intermediate processes and provide appropriate technical support to process teams to sustain and improve the processes. You will ensure flawless execution throughout each assigned campaign, focusing on the fundamentals of safety, quality, supply and cost. Cost Improvement Projects (CIP) development will also be a key part of your role.
As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.
It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
- Will be responsible for leading product manufacturing campaigns from the start of production and providing technical supervision with respect to quality and EHS until completion and release of the material.
- Contribute to achieve our vision of being the best in class manufacturing site, producing highest quality products in the safest way.
- Deploy and use the IMEx "way of working" for day to day operations, problem solving, escalations and continuous improvements.
Core Competencies:
1. Technical Knowledge
2. Communication
3. Teamwork
4. Leadership
5. Management
6. Creativity & Innovation
7. Self-motivated and independent
- Develop Manufacturing/Operating Instructions and necessary Standard Operating Procedures
- Develop, maintain and troubleshoot the process control system recipe/Models Investigate, report and troubleshoot findings on both quality and EHS related issues observed during manufacturing or during batch record review
- Develop, implement and monitor extensive preventive measures for processing issues
- Play a pro-active role in ensuring the site safety and quality standards are adhered to
- Proactively monitor, identify, develop and implement improvements in processes and equipment
- Communicate on a regular basis to the plant personnel on process updates
- Train the process technicians on the process and procedures as required.
- Ensure adherence to approved procedures and update the procedures as required, including the principles and practices of good data management (ALCOA)
- Focus on Safety and GMP Compliance as operational priorities and as performance measures"
- Account able for the Good Data Management and Data integrity understanding and performance.
- Report and investigate actions or behaviors that may negatively impact the desired outcome of the GMP process or activity.
- Own on or more multiple equipment/GMP systems in production and present the system overview with evidence compliance to internal and external auditors.
- Develop courses of action and drive implementation of solutions
- Play an active and impactful role to deliver flawless execution for respective PCTs (e.g. API, MS, 00, Leadership, Engineering) by updating performance against metrics, highlighting & resolving issues with appropriate escalations.
- Work with the PCT to identify and drive improvement as per continuous improvement (Cl) goals of the PCT.
- Uphold Pfizer's code of conduct and values
- Senior position is expected to perform coaching role to junior engineers and manage more complex manufacturing and operation issues. Also expected to lead working teams managing projects to support manufacturing processes.
- Collaborate with cross-functional teams to drive flawless execution. Internal Stakeholder includes:
- Operation - for supporting operation team to meet production targets in cycle time and output
- Supply Chain - for ensuring availability of raw materials for production and supply of finished products to the market, for qualification of alternate source of material/consumables
- Quality - for production batch release and production investigation/improvement
- Engineering - for equipment readiness and production investigation/improvement
- EHS - for performing safety review of changes in the manufacturing processes and in safety related investigation
- Technical Services -for product chemistry, process design understanding, production investigation improvement and product transfer
- External Stakeholders: Equipment Vendors and raw material suppliers - for new materials/equipment/consumables sourcing and during process investigation/improvement
Internal Stakeholders:
- Operation - for supporting operation team to meet production targets in cycle time and output. To support in the training to the production technicians on the process and procedures as required.
- Supply Chain - for ensuring availability of raw materials for production and supply of finished products to the market
- Quality - for production batch release, production investigation/improvement, process validation
- Engineering - for equipment readiness and production investigation/improvement
- Procurement - for new material/consumables supply
- EHS - for performing safety review of changes in the manufacturing processes and in safety related investigation
External Stakeholders:
- Equipment Vendors and raw material suppliers - for new materials/equipment/consumables sourcing and during process investigation/improvement
Qualifications
Must-Have
- 5+ years of experience
- Knowledge of Good Manufacturing Practices, Good Documentation Practices, experience in pharmaceutical environment.
- Experience of project orientated admin/cost control/management.
- Broad knowledge of theory and principles within a professional discipline or advanced knowledge of specific technical/operational practices.
- Strong technical, management and organizational skills.
- Good team player and communication skills
Nice-to-Have
- Master's degree
- Relevant pharmaceutical experience
- Prior experience with Empower, gQTS, and Manager Laboratory Information Management System
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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