In-Demand Quality control associate Jobs in Moorabbin, Vic

Senior Quality Associate (Validation)
PCI Pharma Services —Moorabbin VIC
- Full-time
- Microsoft Word
- Microsoft Excel
- Bachelor's degree
22h
Support Services Associate
St Vincent's Health Australia —Melbourne VIC
- $65,042 a year
- Part-time
- Customer service
- Communication skills
1d
Operations Associate
Wesco —Melbourne VIC
- Overtime
- Forklift
- Warehouse
- Employee assistance program
22h
Building Associate
Metroplant & Civil Services —Sunshine VIC
- Up to $82,000 a year
- Full-time
- Hybrid work
- Construction experience
- In-person
- Communication skills
Quick Apply
Accounts Payable | Senior Associate
PWC Australia —Southbank VIC
- Communication skills
9d
Analyst, Quality Control, Chemistry & Stability
Moderna, Inc. —Melbourne VIC
- Full-time
- Laboratory
- Bachelor's degree
- In-person
- Annual leave
Escala - Wealth Management - Graduate Opportunity
Focus Partners Australia & Escala Partners —Melbourne VIC
- Part-time
- Microsoft Excel
- Finance
- Administrative experience
Quick Apply
Associate Sitecore Developer
Mecca Brands Pty Ltd —Richmond VIC
- Full-time
- Azure
- Software development
- APIs
9d
Escala - Wealth Management - Graduate Opportunity
Focus Financial Partners —Melbourne VIC
- Part-time
- Microsoft Excel
- Management
- Finance
14d
Data Governance Analyst | Senior Associate
PWC Australia —Southbank VIC
- Contract
- Writing skills
- Analysis skills
- Organisational skills
- Parental leave
Enterprise PM Practice Associate
Head Office St Kilda Rd —Melbourne VIC
- Full-time
- Management
- PMP
- Analysis skills
Associate Consultant
L.E.K. Consulting —Melbourne VIC
- Analysis skills
- Leadership
Associate Director / Director | Information, Content & Regulatory Transformation
Deloitte —Melbourne VIC
- SharePoint
- AI
- Communication skills
- Parental leave
Associate Data Scientist
Culture Amp —Melbourne VIC
- Master's degree
- SQL
- Machine learning
- Health insurance
- Parental leave
Associate Project Manager
Saab —Melbourne VIC
- Full-time
- Hybrid work
- Administrative experience
- Communication skills
- Annual leave
- Work from home
Client Service Associate
Richemont —Melbourne VIC
- Weekend availability
- Management
- Sales
- Communication skills
Senior Associate, Intellectual Property
Allens —Melbourne VIC
- Full-time
- Hybrid work
- Supervising experience
- Organisational skills
- In-person
- Health insurance
- On-the-job training
Coordinator
Ecolab Inc. —Cheltenham VIC
- Full-time
- ERP systems
- Organisational skills
Concierge
Marriott International, Inc —Melbourne VIC
- Full-time
- No experience needed
- Senior Secondary Certificate of Education
- Education
3d
Senior Associate – Performance Improvement
Alvarez & Marsal —Melbourne VIC
- Microsoft Powerpoint
- Microsoft Excel
- English

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

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

quality control associate jobs near moorabbin, vic

Associate Director jobs in Melbourne VIC

Concierge jobs in Melbourne VIC

Data Scientist jobs in Melbourne VIC

Operations Associate jobs in Melbourne VIC

Operations Analyst jobs in Melbourne VIC

General Clerk Customer Service Officer jobs in Dulwich Hill Nsw

Accounts Payable Clerk jobs in Wantirna Vic

Accounts Payable Clerk jobs in Doncaster Vic

Accounts Payable Clerk jobs in Mansfield Qld

Accounts Payable jobs in Monash University Vic

Accounts Payable Clerk jobs in St Kilda Vic

Accounts Payable Team Leader jobs in Perth Wa

Assistant Director Childcare jobs in Ropes Crossing Nsw

Culinary Director jobs in Parramatta Nsw

Entry Level Warehouse Associate jobs in Mitcham Vic

Associate Director jobs in University Of Western Australia Wa

Associate Director jobs in Sydney Nsw

Associate Director jobs in Melbourne Eastern Suburbs Vic

Associate Director jobs in New South Wales

Php Developer jobs in Sydney Nsw

Senior Quality Associate (Validation)

PCI Pharma Services -
Moorabbin VIC

Apply Now

Job Details

Full-time
22 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 control associate jobs in moorabbin, vic

Senior Quality Associate (Validation)

Support Services Associate

Operations Associate

Building Associate

Accounts Payable | Senior Associate

Analyst, Quality Control, Chemistry & Stability

Escala - Wealth Management - Graduate Opportunity

Associate Sitecore Developer

Escala - Wealth Management - Graduate Opportunity

Data Governance Analyst | Senior Associate

Enterprise PM Practice Associate

Associate Consultant

Associate Director / Director | Information, Content & Regulatory Transformation

Associate Data Scientist

Associate Project Manager

Client Service Associate

Senior Associate, Intellectual Property

Coordinator

Concierge

Senior Associate – Performance Improvement

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

Related Searches

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected