Operational Quality Assurance Team Coordinator
Duchnice
Boost your career with us
Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion.
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Your role:
Key element of the role is to assure ongoing compliance of production, quality control and warehouse activities, facilities and processes with quality and industry regulatory requirements and internal quality standards, policies, and procedures.
Your responsibilities
- Supervision of the manufacturing activities on the floor – procedure adherence, records revision, cleanroom conducts, aseptic technique, data integrity
- Lead and monitor risk management activities within production area
- Participation in batch records’ creation and verification of the records
- Identification of training needs and organization of training interventions to meet quality standards
- Participation in implementation of the Company's projects
- Implementation of quality process improvements
- Monitoring of key quality indicators in Operational QA Team
- Performing other tasks assigned by the Manager within the scope of tasks of the QA Department
- Participation in investigations related to manufacturing deviations – leading role in RCA for the deviations and complaints, assessment of the impact on change control, planning additional tests if required, risk analysis, proposing CAPA and monitoring of their effectiveness
- SME assessment of Production, Quality Control, Warehouse and QA procedures
- Participation in internal and clients’ audits, and inspections of other pharmaceutical authorities as well as verification of the of post-audit observations
- Assessment of planned changes, execution of activities resulting from change control process
- Active participation in the development, revision, and approval of system documents
- Gathering data and reporting of results for key quality performance indicators
- Leading role in process FMEA, risks identification, defining mitigation measures, CQA and CPPs
- Acting on behalf of Operational Quality Assurance Manager
- Supervision of activities performed by the subordinate team members to ensure they performed to satisfactory quality and in timely manner
- Organization of daily duties for a team of up to 5 employees
If you have:
- University degree (preferably: biotechnology, microbiology, chemistry, pharmacy or related) or documented effective experience in a similar position in a pharmaceutical company
- 5+ years of working experience in GMP regulated biotechnological industry
- Ability to organize work and make decisions under time pressure
- Knowledge of biotechnological manufacturing technologies of pharmaceutical products and active ingredients, as well as principles of GMP, Pharmaceutical Law, ICHQX, EMA, PIC/S, WHO, ISPE, PDA, EU GMP Annex 1, 2, 15, 16
- Basic knowledge of qualification and validation processes
- Communication and interpersonal skills, teamwork skills, ability to effectively transfer knowledge via training process
- Ability to solve problems and perform complex tasks
- Active knowledge of English allowing effective communication in written and verbal format as well as writing reports using formal and scientific English terminology
- Ability to work with MS Office
- Analytical skills in the field of trend analysis, statistical data processing