In-Demand Quality control associate Jobs in Melbourne, Vic

Senior Quality Associate (Validation)
PCI Pharma Services —Moorabbin VIC
- Full-time
- Microsoft Word
- Microsoft Excel
- Bachelor's degree
3d
Associate Director / Director | Information, Content & Regulatory Transformation
Deloitte —Melbourne VIC
- SharePoint
- AI
- Communication skills
- Parental leave
Associate Project Manager
Saab —Melbourne VIC
- Full-time
- Hybrid work
- Administrative experience
- Communication skills
- Annual leave
- Work from home
Associate, Operational Risk - Procurement, Property, Transformation & GCC
ANZ Banking Group —Melbourne VIC
- Full-time
- Analysis skills
18h
Associate Director, Security Programs & Assurance
Sourceo —Melbourne VIC
- Contract
- Management
- Schematics
- Leadership
4d
We need a superstar dental receptionist!
Burgundy Street Dental Clinic —Heidelberg VIC
- $32 - $40 an hour
- Part-time
- Organisational skills
- In-person
- Medical terminology
Quick Apply
Onsite Merchant Support Specialist
ShipBob, Inc. —Altona VIC
- Full-time
- Management
- English
- In-person
Quick Apply
Associate Director - Deals Advisory Services
KPMG —Melbourne VIC
- Full-time
- Microsoft Excel
- Finance
- Analysis skills
- Parental leave
Sr / Engagement Manager
Workday —Melbourne VIC
- Full-time
- PMP
- Bachelor's degree
- No degree
7d
Associate Director, Security Programs & Assurance
AirTrunk —Melbourne VIC
- Management
- Schematics
- Leadership
Quick Apply
Manager, Technology Risk Consulting
Grant Thornton Australia —Melbourne VIC
- Full-time
- Hybrid work
- Management
- Leadership
- Health insurance
- Parental leave
Senior Clinical Research Associate - FSP Melbourne / Sydney
Fortrea —Melbourne VIC
- Full-time
- Management
- Patient monitoring
- Administrative experience
Power Apps Developer
Victorian Government —Melbourne VIC
- $116,413 - $140,849 a year
- Full-time
- Azure
- Management
- APIs
7d
Events Service Manager
Park Hyatt Melbourne —Melbourne VIC
- Weekend availability
- Management
- Administrative experience
- Budgeting
- Health insurance
- Annual leave
Audit Manager
Marsh —Melbourne VIC
- Full-time
- Hybrid work
- Finance
- Analysis skills
- Education
Senior Associate, Internal Audit - Financial Services
Grant Thornton Australia —Melbourne VIC
- Full-time
- Analysis skills
- Financial services
- Gym membership
Account Manager
Solenis —Melbourne VIC
- Full-time
- Customer service
- Maintenance
- Plumbing
14d
Accounting Advisory, Senior Associate
Scyne Advisory —Melbourne VIC
- Full-time
- Finance
- Bachelor's degree
- Accounting
- Annual leave
- Parental leave
Quick Apply
Paid Social Associate Partner (Melbourne)
Open Partners —Melbourne VIC
- Hybrid work
- AI
Quick Apply
Associate Electrical Engineer (Water)
WSP —Melbourne VIC
- Management
- Bachelor's degree
- Communication skills
- Employee stock purchase plan
- Parental leave

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Senior Quality Associate (Validation)

PCI Pharma Services -
Moorabbin VIC

Apply Now

Job Details

Full-time
3 days 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

#LI-AK2

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 control associate jobs in melbourne, vic

Senior Quality Associate (Validation)

Associate Director / Director | Information, Content & Regulatory Transformation

Associate Project Manager

Associate, Operational Risk - Procurement, Property, Transformation & GCC

Associate Director, Security Programs & Assurance

We need a superstar dental receptionist!

Onsite Merchant Support Specialist

Associate Director - Deals Advisory Services

Sr / Engagement Manager

Associate Director, Security Programs & Assurance

Manager, Technology Risk Consulting

Senior Clinical Research Associate - FSP Melbourne / Sydney

Power Apps Developer

Events Service Manager

Audit Manager

Senior Associate, Internal Audit - Financial Services

Account Manager

Accounting Advisory, Senior Associate

Paid Social Associate Partner (Melbourne)

Associate Electrical Engineer (Water)

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

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