Manufacturing Process Specialist
3 weeks ago
Why Patients Need You
At 1G0 Hospira Australia Pty Ltd, our pharmaceutical manufacturing team plays a vital role in bringing life-changing medicines to patients. We're seeking a skilled Senior Associate to join our team and contribute to our mission. As a key member of our team, you will help ensure that patients and physicians have the medicines they need, when they need them.
What You Will Achieve
As a Senior Associate, you will be responsible for contributing to the completion of complex projects, managing your time to meet agreed targets, and developing plans for work activities on your own projects within a team. You will also take the lead in executing line preparation and operation during qualification activities, including developing timelines and resource allocation to achieve defined outcomes.
Key Responsibilities
- Contribute to the completion of complex projects and manage your time to meet agreed targets.
- Take the lead in executing line preparation and operation during qualification activities.
- Develop and validate manufacturing processes for drug products.
- Create and review Good Manufacturing Practices documentation, including batch records, product-specific cleaning assessments, and Standard Operating Procedures.
- Support manufacturing in trouble-shooting investigations and own Corrective Action/Preventative Action to prevent recurrence.
- Deliver reporting and analytics on project activities and operational performance metrics to enable insightful decision-making by the management team.
- Coordinate collaboration with members of project teams, colleagues in relevant teams, contractors, and suppliers to achieve alignment on objectives and expectations.
- Provide operations expertise in new line/processes that the role is directly associated with/responsible.
- Lead all applicable Environmental-related tasks, initiatives, training, and services that adhere to Pfizer Global Environment, Health & Safety Standards, state, and federal regulatory compliance.
- Take initiative to identify continuous improvement opportunities and devise solutions for management's consideration.
- Provide training instructions, guidance, and coaching to team members on manufacturing practices, systems, and technicalities to support their learning and development.
- Provide subject matter expert input to regulatory inspections.
- Ensure adherence to compliance and data integrity requirements.
Qualifications
Must-Have
- Bachelor's Degree.
- 3+ years of experience.
- Excellent communication and organizational skills.
- Demonstrated experience in participating or leading projects to achieve defined business outcomes and meeting delivery timelines and standards.
- Excellent investigation and problem-solving skills to effectively execute and guide technical troubleshooting.
- Strong capability to work with relevant manufacturing software and systems and drive decision-making using data and analytics.
- A high level of understanding of safety regulations and protocols applying to the industry and work area.
- Strong organizational skills with the ability to effectively prioritize tasks and work both independently and as part of a team.
- Ability to provide coaching and mentoring to less experienced colleagues and develop team capabilities.
- Flexibility to work across a variety of shifts as required to support the project.
- Strong work ethic and commitment to quality and continuous improvement.
Nice-to-Have
- Master's degree.
- Relevant pharmaceutical industry experience.
Work Location Assignment
On Premise
At 1G0 Hospira Australia Pty Ltd, we care about our colleagues' wellbeing and offer a range of great benefits for them, including:
- Paid parental leave
- Access to Health & Wellness apps
- Career Growth Experiences program
- Recognition & rewards program
- Paid volunteer days
- Life Insurance Benefits
- Pfizer Learning Academy access to top content providers
- Access to flu vaccines & skin checks
- Options to purchase additional leave
- Salary packaging & novated lease options
Pfizer Australia and New Zealand's diverse workforce represents the patients we serve and the communities in which we operate. With a focus on Diversity, Equity & Inclusion (DE&I), Pfizer ANZ ensures our people are heard and cared for. We offer engagement opportunities in both Colleagues Resource Groups (CRGs) and workstreams across: Culture and Tradition, Reconciliation @ Pfizer (RAP), Gender Equity (GEN), Disability and through the Out Pfizer Employee Network (OPEN) for our LGBT+ colleagues and allies.
If you require reasonable adjustment during your application, please reach out to the Talent Acquisition Manager.
Manufacturing
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