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Production Compliance Specialist

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Pfizer

2mo ago

  • Job
    Full-time
    Mid & Senior Level
  • Melbourne
  • Quick Apply

AI generated summary

  • You need a science or engineering degree, 3-5 years in pharma, GMP knowledge, strong communication skills, project management experience, and attention to detail with a focus on quality systems.
  • You will manage change requests, update documentation, coordinate with departments, prepare metrics, assess risks, and analyze data to improve compliance and reduce waste.

Requirements

  • Must-Have
  • Bachelor’s degree in science, Engineering, or a related discipline, or equivalent experience in the pharmaceutical or allied industry.
  • 3-5 years of experience within the pharmaceutical or allied industry.
  • Knowledge and application of Good Manufacturing Practices (cGMP).
  • Exceptional communication, negotiation, interpersonal, and leadership skills (verbal and written).
  • Results-focused with demonstrated Project Management skills, the ability to manage multiple projects, and meet business targets and delivery timelines.
  • Attention to detail, technical knowledge, innovative thinking, and problem-solving abilities, including implementation of resolutions.
  • Ability to work under pressure and meet agreed timelines with high attention to detail.
  • Understanding of quality systems, including CAPA/CI management, change controls, and quality records.
  • Proficiency with computer packages, including the Microsoft Office suite.
  • Permanent rights to work within Australia.
  • Preferred Qualifications
  • Experience in sterile manufacturing, Process Validation, Engineering, or Quality.
  • Method 1 (M1) and Pfizer Human Performance (PHP) certification.
  • Demonstrated ability and accountability to meet business targets and objectives.
  • Strong awareness of GxP requirements and a proponent of “Best-Practice” Quality Standards.
  • Demonstrated initiative and ownership in resolving issues or challenges.
  • Participation in the generation and implementation of continuous improvement (CI) ideas.
  • Ability to occasionally work outside standard hours to accommodate all production shifts and business needs.

Responsibilities

  • Supporting the production teams by managing change requests and updating documentation.
  • Manage associated change controls and assist with the scheduled periodic review of production documentation.
  • Independently coordinate with requesting departments to obtain supporting information, resolve change control issues, and facilitate the review/approval/implementation of changes.
  • Update documentation to align with company policies, practices, and standards.
  • Implement strategies to improve performance and reduce waste through proactive CAPAs and CI initiatives.
  • Preparing monthly and or weekly departmental metrics related to change control and document control processes.
  • Report performance against established standards in line with company objectives.
  • Participate in risk assessment activities.
  • Communicate the strategic plan objectives of the department in daily activities.
  • Foster an environment of open communication and recognition of contribution.
  • Collaborate with business process owners to conduct regulatory requirements gap assessments and implement necessary actions to address any identified gaps.
  • Perform all operations within the Functional Unit according to relevant procedures and standards.
  • Facilitate or complete production compliance activities outside standard working hours as needed.
  • Conduct complex data gathering and analysis using Excel and MiniTab.

FAQs

What is the main responsibility of the Production Compliance Specialist?

The main responsibility of the Production Compliance Specialist is to support the production teams by managing change requests, updating documentation, overseeing change controls, and implementing strategies for performance improvement and waste reduction.

What qualifications are required for this position?

A Bachelor’s degree in science, engineering, or a related discipline, along with 3-5 years of experience in the pharmaceutical or allied industry, is required. Knowledge of Good Manufacturing Practices (cGMP) is also essential.

Is experience in sterile manufacturing preferred for this role?

Yes, experience in sterile manufacturing, Process Validation, Engineering, or Quality is preferred for this position.

What type of communication skills are necessary for this job?

Exceptional communication, negotiation, interpersonal, and leadership skills (both verbal and written) are necessary for the Production Compliance Specialist role.

To whom will the Production Compliance Specialist report the status of compliance activities?

The Production Compliance Specialist will report the status of manufacturing compliance activities and closure plans to key stakeholders.

Does the company offer any benefits for its employees?

Yes, the company offers a range of benefits including paid parental leave, access to health and wellness apps, recognition and rewards programs, and life insurance benefits, among others.

What tools will the Production Compliance Specialist use for data gathering and analysis?

The Production Compliance Specialist will conduct data gathering and analysis using tools like Excel and MiniTab.

Is a position in this role permanent?

Yes, the position requires candidates to have permanent rights to work within Australia.

What is the work location for this role?

The work location for this role is on-premise.

Are there opportunities for career growth within this position?

Yes, the position includes a Career Growth Experiences program that provides opportunities for professional development.

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Pfizer

Pharmaceutical Manufacturing

Science & Healthcare
Industry
10,001+
Employees
1849
Founded Year

Mission & Purpose

Pfizer is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative healthcare solutions. They are committed to improving the health and well-being of people around the world. Pfizer's mission is to be a leading force in the fight against diseases and to provide access to safe, effective, and affordable medicines. Their purpose is to make a positive impact on society by advancing medical science, developing breakthrough therapies, and collaborating with healthcare professionals and partners to address unmet medical needs. With a focus on research, development, and the production of pharmaceutical products, Pfizer plays a vital role in shaping the future of healthcare and improving patient outcomes.