CV Keskus job ad (Senior) Associate-SAP Quality Solutions, 2022-08-01

Job Description

Pfizer is taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for people. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will be a member of Pfizer's dedicated and highly effective quality assurance and control team. You will be responsible for activities involved in quality oversight for change control system, product change control oversight with Regulatory Affairs and APR program management. You will also be relied on to support non-manufacturing functions, quality strategic planning, performance metrics and quality goals and objectives. You will also quality provide related oversight for other functions.

As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

How You Will Achieve It

Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
Review and interpret metrics, provide assistance and input to determine action plans needed to maintain or improve the state of compliance in Change Management Quality System.
Perform Risk Assessments for Validation systems.
Remain up to date on current Regulatory trends as well as Pfizer Quality Standards.
Conduct product Quality Assurance Professional (QAP) updates in Quality Information system (QIS) system.
Schedules and manages calibration/maintenance service contracts with outside vendors and maintain calibration database.
Participate in internal audit program as auditor.
Support realization of the site self-assessment program by conducting internal audits/ walkthroughs, ensuring the follow-up on corrective/preventive actions, and assisting with Inspection Readiness.
Participate and contribute on group engagement teams to evaluate and recommend improvements to equipment and general laboratory process
Assist with the creation of clear and concise parent change records to support Good Manufacturing Practices {also cGMP} changes.

Requirements

Must-Have

Bachelor's degree (Any Science related) is required
1-4 years of work experience is needed. SAP experience or Pharma is a plus
Excellent written and oral communication skills to enable interactions at various levels in the organization
Understanding of Chemical or Pharmaceutical business process and key success factors for business performance
Knowledge of SAP Quality Module or systems design and deployment experience is a plus
Facilitation and presentation skills
Ability to work in ambiguous situations
Demonstrated skills in analysis and problem solving
Experience using standard requirements business analysis techniques, including brainstorming, interviewing, requirements sessions, activity diagrams and use cases desired
Demonstrated ability to perform technical project management
Knowledge of software development life cycles and project management processes
Able to work on cross-functional teams and independently
Excellent verbal and written communications skills with the ability to effectively communicate with project stakeholders and senior business leadership

Nice-to-Have

Master's degree
Demonstrated ability to learn and master new applications software
Experienced in auditing with Good Manufacturing Practices (also cGMP) regulated industries

Company offers

At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives. Pfizer's open-door policy is an integrated part of our culture across all levels of seniority.We offer possibilities for working from home (up to 3 days per week) and flexible working hours.Competitive salaries and benefit packages : meal vouchers, DKV hospitalisation, outpatient, dental, pension plan, phone, public transport reimbursement.Unparalleled opportunities for career growth: trainings, possibilities for internal mobility, temporary assignments…We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

We offer possibilities for working from home (up to 3 days per week) and flexible working hours.

Competitive salaries and benefit packages : meal vouchers, DKV hospitalisation, outpatient, dental, pension plan, phone, public transport reimbursement.

Unparalleled opportunities for career growth: trainings, possibilities for internal mobility, temporary assignments…

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.