Qc Microbiology Team Leader

1 month ago

Mulgrave, Australia Pfizer Full time

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will train others and reinforce behaviors that will help us achieve our goal of providing the best healthcare to our patients.

How You Will Achieve It
- Review and introducing systems and practices that enable the Functional Unit to meet business demands within agreed timeframes and expected cGLP standards.
- Ensures all OOS & non-compliance investigations & reporting functions within the Functional Unit are completed in a timely fashion.
- Ensures that testing requirements are scheduled to deliver results within expected lead times, and to provide timely feedback to customers manager when delays to product availability occur.
- Reports KPI’s for the Functional Unit.
- Focus on Safety and GMP Compliance as operational priorities and as performance measures that should be included in metrics.
- Know the processes and procedures, including the principles and practices of good data management (ALCOA), and be able to guide, advise and coach their team.
- Reviews and where appropriate rationalizes processes and tasks to deliver efficiencies and cost saving.
- Develop staff relationships with the assigned team.
- Engage and inspire their team on performance expectations and coach the team to meet those expectations using Coaching Skill principles.
- Lead and support continuous improvement efforts, where applicable.
- Be a role model to support a positive compliance culture.
- Act as a stand in for the Microbiology Laboratory Coordinator as assigned by the supervisor, in the absence of the Microbiology Laboratory Coordinator or as required.
- Liaises with Key representatives of customer departments to ensure effective communication channels are maintained, and to assess the effectiveness of the Functional Units service delivery.
- Be accountable for the Good Data Management and Data Integrity understanding and performance of their team.
- Effectively monitor the actions of their team. Ensure and active daily presence in the GMP work area and observe the work activity and practices within their role responsibilities.
- Be available to their direct reports for real time escalations of any concerns or support needs.
- Be observant, investigate and report actions or behaviours that may negatively impact the desired outcome of the GMP process or activity.
- Review the content of all Leader Led Conversations and, on an annual basis, conduct two ‘Leader Led Conversations with their team aimed at fostering a culture that supports compliance with procedures including good data management.
- Be vigilant for potential actions or behaviours that could result in breaches of GMP compliance or Data Integrity principles.
- Perform QC Filled Product / Raw Material / Component release and Stability authorization for respective area.
- Complete documentation reviews of QC Microbiology documentation as an SME.
- Coordinate and perform laboratory investigations and implement any resulting corrective actions.
- Performs risk assessment investigations within the Functional Unit and oversees strategies to reduce identified business risks.
- Ensures KPI’s are monitored, maintained and reported monthly/weekly for the Functional Unit, assists in the development of future performance targets.
- Carries out performance appraisals and ensures appraisals are conducted on time.
- Pro-actively manage, identify and report occupational health and safety issues, addressing identified issues and implementing risk reduction initiatives to remove potential safety risks when required.
- Assist with preparation and presenting in audits (internal or external).

**Qualifications**:
Must-Have
- Bachelor of Science or related discipline.
- Relevant supervisory experience within a laboratory or Production/Manufacturing environment.
- Competent in core IT systems (e.g. MS-office, LIMS).
- Strong awareness of GxP requirements and a proponent of “Best-Practice” Quality Standards.
- Ability to plan and organise priorities and to initiate timely issue resolution mindful of customer service requirements.
- Demonstrates initiative and ownership in resolving issues or challenges.
- Demonstrates problem solving and negotiation skills.
- Excellent communication skills, both verbal and written.
- Strongly quality and customer focused.

Nice-to-Have
- Masters Degree

Work Location Assignment: On Premise

At Pfizer 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 & re

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