Senior Quality Associate (Validation)

PCI Pharma Services; City of Melbourne; On-site; AUD 110,000 - 170,000; Full time

Job summary

PCI Pharma Services is seeking a Senior Quality Associate – Validation in Melbourne to lead the development, execution, and maintenance of a robust Validation Program across facilities, utilities, equipment and software. You will oversee qualification activities, write and approve master plans, procedures and reports, and provide training to teams to ensure GMP compliance.

This role requires a strong background in cGMP manufacturing, lifecycle validation, and QA processes, with experience audits

Qualifications

• Bachelor of Science, Pharmacy or related Discipline.
• Five years experience in cGMP pharmaceutical manufacturing facility, ideally in a Validation role.
• Proficient user of Microsoft Word and Excel.
• Experience in Validation and life cycle management.
• Experience in using a e-Quality Management System in a pharmaceutical company.
• Experience in customer and regulatory authority audits.

Responsibilities

• Lead design and development of Qualification and Validation program compliant to PIC/s and risk management.
• Write, review and approve qualification/validation procedures, master plans, forms, templates, protocols and reports.
• Lead execution and maintenance of the validation schedule to ensure adherence and escalations.
• Support qualification/validations of facilities, utilities, equipment and software.
• Provide quality oversight of asset systems and review calibration/maintenance records.
• Support improvements/upgrades of GMP software systems as required.
• Provide training to new and existing employees in Validation.
• Review and approve protocols and reports from third parties providing validation services.
• Write/review deviations to determine root cause and impact.
• Approve release of validation activities to next stage.

Skills

Communication

Analytical thinking

Team player

Problem solving

Quality mindset

Detail oriented

Education

Bachelor of Science, Pharmacy

Tools

Microsoft Word

Microsoft Excel

Job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Purpose:

• The Senior Quality Associate – (Validation) is accountable for leading and executing the development, implementation, execution and maintenance of a robust and compliant Validation Program which includes: Site Validation Master Plan (VMP), Cleaning VMP, Facilities, Utilities, Equipment and Software Qualification (IQ/OQ/PQ), and Process Validation (PV).

Primary Responsibilities:

• Lead the design and development of the Qualification and Validation program compliant to PIC/s and quality risk management principals


• Write, review and approve (as required) qualification/validation procedures, master plans, forms, templates, protocols and reports


• Lead the execution, monitoring and maintenance of the validation schedule to ensure schedule adherence and required escalations


• Support and executes qualification/validations of (including but not limited to) facilities, utilities, equipment and software


• Provide quality oversight of the asset system (i.e. Blue Mountain) and reviews and approves completed calibration/ maintenance records


• Support improvements/upgrades of other GMP software systems as required


• Provide training to new and existing employees in Validation


• Review and approve protocols and reports supplied by Third Parties providing validation services to confirm suitability and compliance to internal procedures


• Write and reviews qualification/validation deviations to determine root cause and potential impact to the qualification/validation


• Approves the release of the validation activities to the next stage of the


• qualification/validation


• Lead and writes periodic evaluations, and determines requirements for


• requalification/revalidation


• Lead and executes the design, execution and monitoring of decommissioning activities, process validation and cleaning validation activities, including needs assessments


• Support the assessment of test method validation (as required)


• Qualification/Validation subject matter expert for risk assessments


• Review and approve change controls pertaining to potential recommissioning and/or qualification/validation activities for new, current or transferred equipment and processes


• Provides direction and expertise to employees to ensure the development and implementation of departmental SOPs that are compliant to regulatory requirements, and are 'fit for purpose' operationally and commercially.


• Participate in the PCI Centres of Excellence as appropriate with the goal of


• harmonising quality systems across all PCI sites as part of the company’s One PCI policy.


• Collaborate with other PCI stakeholders including Project Management, Warehouse, Human Resources, Production etc where required


• Reports metrics related to Validation and assist with the preparation of the Quality Management Review


• Support the completion of other compliance team responsibilities as required (e.g., Supplier Management, CAPA completion, Deviation investigations and Customer Complaint investigations, Client audits, Internal audits, Regulatory audits etc)


• Ensure all activities in area of responsibility are performed in accordance with GMP, company SOPs and Health and Safety policies.


• Escalate quality issues to the Quality Compliance and Systems Manager as required


• Other duties as required by Manager

Qualifications & Experience:

• Bachelor of Science, Pharmacy or related Discipline


• Five years experience in cGMP pharmaceutical manufacturing facility, ideally in a Validation role


• Proficient user of Microsoft Word and Excel


• Experience in Validation and life cycle management


• Experience in using a e-Quality Management System in a pharmaceutical company


• Experience in customer and regulatory authority audits.

Behavioural Competencies:

• Communication and responsiveness at all times


• Positive, 'can-do' attitude, embraces and 'lives' PCI's Vision and Values


• Analytical thinker and solution finder/problem solver


• Collaborative, team player


• Objective and robust decision maker


• Excellent interpersonal, written and verbal communication


• Self-motivated and achievement orientated


• Trusting and trustworthy


• Conscientious and diligent


• Positive, embraces and responsive to change

Join us and be part of building the bridge between life changing therapies and patients.

Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer.

We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies.

We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level.

We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.