In-Demand Quality associate Jobs in Melbourne, Vic

Senior Quality Associate (Validation)
PCI Pharma Services —Moorabbin VIC
- Full-time
- Microsoft Word
- Microsoft Excel
- Bachelor's degree
2h
Support Services Associate
St Vincent's Health Australia —Melbourne VIC
- $65,042 a year
- Part-time
- Customer service
- Communication skills
10h
Medical Information Associate
PrimeVigilance —Melbourne VIC
- Full-time
- Remote
- Management
- Customer service
- Writing skills
Quick Apply
1d
Food Services Associate
Epworth —Richmond VIC
- Weekend availability
- Hospitality
- Customer service
- Food service experience
- Relocation assistance
Quick Apply
Operations Associate
Wesco —Melbourne VIC
- Overtime
- Forklift
- Warehouse
- Employee assistance program
2h
Associate Environmental Planner
Jacobs —Melbourne VIC
- Part-time
- Hybrid work
- Organisational skills
- Communication skills
- Parental leave
2d
Management Consulting - Expression of Interest
Grant Thornton Australia —Melbourne VIC
- Full-time
- Master's degree
- Business development
- Business Administration
- Parental leave
- Gym membership
Seasonal Store Associate - The Ordinary - Gertrude St
DECIEM —Melbourne VIC
- Temporary
1d
Claims Associate
TAL —Melbourne VIC
- Full-time
- Hybrid work
- Customer service
- Medical terminology
Quick Apply
7d
Advanced Associate, Content Researcher
Pearson —Melbourne VIC
- Full-time
- Writing skills
- Research
- Communication skills
Associate Kit Assembler
Stryker —Melbourne VIC
- Full-time
- Leadership
- Health insurance
- Annual leave
13d
Case Manager & Case Management Associate - Expression of Interest
Toll Group —Melbourne VIC
- Full-time
- Case management
- Communication skills
- Time management
Escala - Wealth Management - Graduate Opportunity
Focus Financial Partners —Melbourne VIC
- Part-time
- Microsoft Excel
- Management
- Finance
13d
Clinical Research Associate
The Royal Melbourne Hospital —Parkville VIC
- Part-time
- Patient monitoring
- Research
- Communication skills
Junior Strategy Consultant | Senior Associate | Strategy&
PWC Australia —Southbank VIC
- Research
- Analysis skills
- Financial services
- Parental leave
22h
Warehouse Pick & Pack Associate (IT Warehouse)
Axiom Technologies —Melbourne VIC
- Part-time
- Warehouse
- Computer skills
- Communication skills
(Fixed-Term) Manufacturing Associate
Moderna, Inc. —Melbourne VIC
- Overtime
- Bachelor's degree
- No degree
- In-person
- Annual leave
Administrative Officer - Office of Cancer Research
Peter MacCallum Cancer Centre —Parkville VIC
- $66,768.00 - $73,811.92 a year
- Full-time
- Hybrid work
- Research
- Microsoft Office
- Administrative experience
- Annual leave
2h
Associate Consultant
Circana Australia —Melbourne VIC
- Hybrid work
- Microsoft Powerpoint
- Microsoft Excel
- Management
Quick Apply
4d
Retail Associate | Oakley | PT | Vic | Chadstone
Oakley —Chadstone VIC
- Sales
- Communication skills

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Senior Quality Associate (Validation)

PCI Pharma Services -
Moorabbin VIC

Apply Now

Job Details

Full-time
2 hours ago

Qualifications

Microsoft Word
Microsoft Excel
Bachelor's degree
Pharmacy
Cleaning
Manufacturing
Communication skills

Full 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. Let’s talk future

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.

Apply Now

Refine Your Search

quality associate jobs in melbourne, vic

Senior Quality Associate (Validation)

Support Services Associate

Medical Information Associate

Food Services Associate

Operations Associate

Associate Environmental Planner

Management Consulting - Expression of Interest

Seasonal Store Associate - The Ordinary - Gertrude St

Claims Associate

Advanced Associate, Content Researcher

Associate Kit Assembler

Case Manager & Case Management Associate - Expression of Interest

Escala - Wealth Management - Graduate Opportunity

Clinical Research Associate

Junior Strategy Consultant | Senior Associate | Strategy&

Warehouse Pick & Pack Associate (IT Warehouse)

(Fixed-Term) Manufacturing Associate

Administrative Officer - Office of Cancer Research

Associate Consultant

Retail Associate | Oakley | PT | Vic | Chadstone

I want to receive the latest job alert for quality associate in melbourne, vic

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