Quality Assurance Associate Manager at PCI Pharma Services

Melbourne, Victoria, Australia -

Full Time

Start Date

Immediate

Expiry Date

24 Sep, 26

Salary

0.0

Posted On

26 Jun, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management Systems, cGMP, e-PQS, MasterControl, BlueMountain, Change Management, Root Cause Analysis, CAPA, Regulatory Compliance, People Management, Internal Auditing, SOP Development, Microsoft Word, Microsoft Excel, Deviation Management, Customer Complaint Handling

Industry

Pharmaceutical Manufacturing

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. Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

Responsibilities

Assist the Quality Assurance Manager in developing and maintaining the Quality Management Systems and e-PQS at the Melbourne site. Oversee compliance, manage GMP software systems, and lead people management responsibilities for direct reports.