Customer Quality Lead

PCI TRGR Penn Pharmaceutical Services Ltd; Ireland; On-site; EUR 45,000 - 65,000; Full time

Job summary

PCI Pharma Services in Ireland is seeking a Customer Quality Lead to plan, direct, and coordinate Quality Operational activities for dedicated customers, ensuring goals are met within time and budget.

The role acts as customer POC, attends meetings, provides QA metrics, and works with QA technicians to ensure batches are reviewed and ready on time; strong communication and problem-solving required.

Qualifications

• Bachelor’s degree in Pharmacy, Microbiology, Chemistry, Biology or related field.
• Minimum 1 year of pharmaceutical industry experience.
• Proficiency with MS Office Suite programs.
• Excellent attention to detail and communication skills.
• Skilled at driving and providing training to other staff members.

Responsibilities

• Assist with record reviews of completed orders and orders in process to ensure cGMP compliance and customer requirements.
• Liaise with customers concerning quality batch documentation.
• Identify, communicate, and track document-related issues with other departments and customers.
• Attend conference calls and customer meetings; provide complaint and quality related information.
• Assist with generating quality metrics and KPIs for team performance.
• Assist with investigations of Quality deviations and drafting of reports.
• Dispositon of Events and NONC’s and address quality events with Production and Quality teams.
• Train, develop and mentor new QA Technician.

Skills

Quality Assurance

Quality Metrics

Documentation

MS Office

Communication

Training

Analytical thinking

Collaboration

Education

Bachelor’s degree in Pharmacy, Microbiology, Chemistry, Biology or related field

Tools

MS Office

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.

Job Description Role Overview Customer Quality Lead (CPL) Plans, directs, and coordinates Quality Operational activities for dedicated customers to ensure that goals and objectives of the team (PCI QA Ops and Customer) are accomplished within prescribed time frames and in budget. Maintains a positive working relationship with internal and external customers. Customer Point of Contact (POC), attending the weekly/monthly meetings, provides QA Operational QKI’s (RFT among others) and works with QA Technician ensuring batches are reviewed and ready for customer as per agreed timelines.

Primary Responsibilities

• Assist with performing record reviews of completed orders and orders in process to ensure compliance with cGMP’s and customer requirements.
• Assist as company liaison with customers concerning quality batch documentation.
• Help identify, communicate, track and resolve document related issues with other departments and customers.
• Attend conference calls and customer meetings; provide complaint and quality related information.
• Assist with generating and presenting quality related metrics and key performance indicators for team’s performance.
• Assist with the investigation of Quality deviations and the drafting of investigation reports associated with such deviations.
• Disposition of Events and NONC’s
• Assist with addressing and documenting quality events with Production and Quality teams.
• Assist with training, developing, and mentoring new QA Technician.
• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
• Attendance to work is an essential function of this position.
• Performs other duties as assigned by Manager/Supervisor.
• Develop, update, and implement procedural changes throughout QA Operations
• Standardize documentation to ensure PCI’s Standard for Quality is achieved throughout our customer base.
• Coach, train, mentor and develop PCI’s employees to ensure Quality Standards are met and maintained.
• Assist with In-Process / Finished Goods Inspections, Annual Retain Inspections, Customer Complaint Samples or Rework as needed to support the various groups throughout PCI.
• Compile, update and analyse customer / internal data and metrics to identify potential trends and areas for opportunities. Utilize the Microsoft Office Suite in detail to present data / facts in a professional fashion.
• Maintain positive external and internal customer relationships with face-to-face, email and voice communication. Provide the appropriate feedback within 24 hours of notification.
• Assist with Supplier Investigations as needed.
• Assess and provide detailed reports / summaries on the impact of process changes to PCI management.

Secondary Responsibilities

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

Requirements

• Bachelor’s degree in Pharmacy, Microbiology, Chemistry, Biology or related fields
• Minimum 1 year of pharmaceutical industry experience
• Ability to work with minimal supervision
• Proficiency with MS Office Suite programs
• Excellent attention to detail
• Superior communication skills
• Skilled at driving and providing training to other staff members
• Strong analytical and problem-solving skills.

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.

#LI-JP1 Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future