IRE_Quality Systems Specialist

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

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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.

Job Title: Quality Systems Specialist JD061 (level 1)

Department: Quality

Division / Section: Quality Assurance

Accountable to: Quality Systems Supervisor

Summary of Role

The role is to implement and execute tasks relating to day-to-day Quality Assurance aspects. The role entails taking responsibility for Quality Assurance matters around processes and documentation in the City North business unit.

Key Responsibilities

· Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.

· Writing and reviewing SOP's, Work Instructions, BPR's and Forms.

· Writing and reviewing of Deviations, Non-Conformance reports, Corrective Action Requests and prepare the final report for QP review.

· Follow up on change control actions with appropriate action owners and drive for on time closure of actions.

· Prepare Quarterly reports for each site.

· Prepare Product Quality Review reports.

· Prepare & present Monthly/Annual Metrics.

· Complete complaints investigations and assist with close out of complaints.

· Perform cGMP internal audits.

· Assist in the performance of external audits (as required).

· Responsible for executing training for quality & other relevant persons.

· Assist with preparation for customer/regulatory audits.

· Assist with audit requests during customer/regulatory audits.

· Prepare responses to customer audits.

· Host/attend cross departmental meetings as required as quality representation.

· Identify and support opportunities for improving processes and or procedures.

· To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities.

· Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company

Knowledge / Skills & Experience

Essential:

· Bachelor’s or associate degree or Diploma / Certificate in GMP, Regulatory and Compliance or similar. May substitute experience in lieu of educational requirements.

· 1+ years’ experience working in GMP or Regulated Environment

· Ability to manage multiple tasks and set priorities.

· Problem Solving and Troubleshooting skills. The successful candidate should display a dynamic and proactive approach to manage problems.

· Self-motivated with a results driven approach.

· Adaptable and ability to work collaboratively.

· Proficient in Microsoft Office products (incl. Excel, PowerPoint, Word, etc.)

· Driving License Required.

Desirable:

· Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements.

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.