In-Demand Assurance associate manager Jobs in Melbourne Vic

Quality Assurance Associate Manager
PCI Pharma Services —Moorabbin VIC
- Full-time
- Microsoft Word
- Microsoft Excel
- Bachelor's degree
Risk & Compliance Consultant/ Associate Manager
Accenture —Melbourne VIC
- Full-time
- Microsoft Powerpoint
- Management
- Microsoft Office
Management Consulting - Expression of Interest
Grant Thornton Australia —Melbourne VIC
- Full-time
- Master's degree
- Business development
- Business Administration
- Parental leave
- Gym membership
GlobalView Lead Implementation Consultant
ADP —Cremorne VIC
- ERP systems
- Human resources
- Time management
- On-the-job training
Advanced Associate, Test Center Support
Pearson —Melbourne VIC
- Full-time
- Microsoft Excel
- Microsoft Office
- Education
Manager, Supply Chain (Life Science / Healthcare)
Cencora —Melbourne VIC
- Full-time
- Hybrid work
- Writing skills
- Analysis skills
- Presentation skills
Interim Operations Shift Manager, AMZL
Amazon Commercial Services Pty Ltd —Ravenhall VIC
- Weekend availability
- Bachelor's degree
Senior Quality Associate
Contract Manufacturing —Melbourne VIC
- Full-time
- Analysis skills
- Bachelor's degree
- Organisational skills
Quick Apply
8d
Service Experience Duty Manager
Marriott International, Inc —Melbourne VIC
- Full-time
- Hospitality
- Management
- Leadership
- Employee assistance program
- Referral program
7d
Senior Associate, Internal Audit - Financial Services
Grant Thornton Australia —Melbourne VIC
- Full-time
- Analysis skills
- Financial services
- Gym membership
Research Assistant - Molecular Haematology
Peter MacCallum Cancer Centre —Parkville VIC
- $73,762 - $105,846 a year
- Full-time
- Laboratory
- Communication skills
- Annual leave
7d
Quality Manager – Release
Blackmores Group —Braeside VIC
- Full-time
- Bachelor's degree
- Agile
- Leadership
1d
Senior Migration Agent - RMA
Knowbal Migration and Education —Melbourne VIC
- $80,000 - $100,000 a year
- Full-time
- Writing skills
- Business development
- Analysis skills
Quick Apply
Concierge - Bell Attendant
Marriott International, Inc —Melbourne VIC
- Full-time
- No experience needed
- Senior Secondary Certificate of Education
- Education
Senior Associate Secondary Engineer
Jacobs —Melbourne VIC
- Hybrid work
- Management
- Leadership
- Communication skills
- Parental leave

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Quality Assurance Associate Manager

PCI Pharma Services -
Moorabbin VIC

Apply Now

Job Details

Full-time

Qualifications

Microsoft Word
Microsoft Excel
PCI
Quality assurance
Bachelor's degree
Pharmacy
Manufacturing
Document management systems
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:

Assist the Quality Assurance Manager in the overall development, maintenance, and continuous improvement of the Quality Management Systems at PCI Melbourne. Specifically, the compliance, management, training, implementation and updates of the PQS and e-PQS, and other GMP software systems requiring quality oversight (including but not limited to MasterControl and BlueMountain).

Maintain robust Quality monitoring (and the review of compliance to metrics) to ensure the assessment of an effective quality management system and the escalation of adverse trends.

Primary responsibilities:

Oversee the overall management of the e-PQS (MasterControl), to ensure day-to-day operational and compliance requirements are met, compliance to regulatory requirements, and local and Corporate PCI procedures. This includes improvements/upgrades and local administrative functions.
Provide quality oversight of site PCI PQS, and support improvements/upgrades of other GMP software systems as required (i.e. BlueMountain)
Manage day-to-day review, approval and routing of GMP software system records (i.e. Mastercontrol, BlueMountain etc).
Manage PQS training to new and existing employees, in the e-PQS (including but not limited to), deviations, customer complaints and CAPA
Manage the review, approval and escalation of events, deviations and customer complaints.
Support the completion of investigations to determine root cause and effective corrective and preventative actions to prevent recurrence
Manage and drive continuous improvements to assist in enhancements in departmental operational performance, compliance to regulatory requirements, improvements in site Standard Operating Procedures (SOPs) and meeting external and internal customer requirements, with respect to quality, service, and lead time.
Provide 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 Centre’s of Excellence as appropriate with the goal of harmonizing 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
Oversee the site Change Management process, and review and approve change requests and change records
Report metrics related to the Quality Management Systems and assist with the assessment of PQS effectiveness.
Drive site improvements to address adverse trends and/or areas of improvement
Support regulatory inspections and act as a subject matter expert in the PCI PQS and e-PQS
Support the completion of other compliance team responsibilities as required (e.g., Supplier Management, Client Audits and Internal Audits etc)

Ensure all activities in area of responsibility are performed in accordance with GMP, company SOPs and Health and Safety policies.
Escalation of quality issues to the Quality Assurance Manager
Other activities as directed by the Quality Assurance Manager or Quality Director
Carry out the following people management responsibilities for direct reports (employees, contractors, casuals etc.) and/or within the Team, in accordance with organisational policies and applicable laws:
Interview, hire and onboard;
Plan, assign/delegate, and direct business priorities and/or work;
Coach, develop and/or train;
Appraise and manage performance and outcomes;
Recognise, reward and discipline; and
Manage workplace issues and address complaints to resolve problems in a timely manner in the event of escalation

Qualifications & experience:

Bachelor of Science, Pharmacy or related discipline.
Ten years experience in cGMP pharmaceutical manufacturing and/or development, ideally in Quality Assurance.
Proficient user of Microsoft Word and Excel
Experience with e-PQS or other electronic document management systems
Experience in maintenance of Quality Management Systems in pharmaceutical companies.
Experience in customer and regulatory authority audits.
Experience in performing an administer function in electronic software systems

Behavioural competencies required for this position:

High level of professionalism, ethics, quality of work, 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

assurance associate manager jobs in melbourne vic

Quality Assurance Associate Manager

Risk & Compliance Consultant/ Associate Manager

Management Consulting - Expression of Interest

GlobalView Lead Implementation Consultant

Advanced Associate, Test Center Support

Manager, Supply Chain (Life Science / Healthcare)

Interim Operations Shift Manager, AMZL

Senior Quality Associate

Service Experience Duty Manager

Senior Associate, Internal Audit - Financial Services

Research Assistant - Molecular Haematology

Quality Manager – Release

Senior Migration Agent - RMA

Concierge - Bell Attendant

Senior Associate Secondary Engineer

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