🇳🇱 Amsterdam, Netherlands · 2h ago
Senior Associate QA - Shifts
Real
LinkedInseniorEnglish-friendly
IMPORTANT INFO:We are looking for an outgoing, multi-tasking mediator with strong communication skills and the ability to work under pressure. GMP experience is a plus.Please note! This is a 3-shift job with the following shift structure One week night shiftOne week late shiftOne week early shiftOne week late shiftOne week early shift Early shift: 06.30 - 15.00 Late shift: 14.30 - 23.00 Night shift: 22.30 - 07.00. Objectives:Provide QA guidance and support in the production area at ABR.Perform batch record review of batches assembled, packaged and labeled at ABR.Establish effective working relationships with Production, Warehouse, Maintenance and Engineering, QA Management and the Qualified Person.Provide daily guidance and support to Production staff in regards to compliance with Standard Operating Procedures and Work Instructions.Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations.Review and approve batch production record data entries before production activities take placePerform finished product checks during (commercial) production runs.Compile and review batch records for lots assembled, packaged and labeled at ABR in preparation for disposition by QP.Perform GMP compliance checks in production.Review and approve deviation records.Initiate and own QA deviations as needed.Act as author for operational SOP's and Work Instructions, as needed.Review of operational SOP's and Work Instructions, as needed.Assist in development and delivery of GMP training activities for QA and production staff.Participate in QA production related projects, as needed.Assist in various investigations, as needed.Assist in ABR projects and improvement efforts, as needed.Responsible for preparation of weekly/monthly metrics.Own and maintain departmental performance boards. Knowledge:Understanding and application of principles, concepts, theories and standards of technical/scientific field.Specialized knowledge within own specialty area.Deepens technical knowledge through exposure and continuous learning.Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery. Problem Solving:Applies research, information gathering, analytical and interpretation skills to problems of diverse scope.Ensures compliance within regulatory environment.Develops solutions to technical problems of moderate complexity.Screens, categorizes, evaluates, reconciles, reports and resolves data integrity issues.Interprets generally defined practices and methods. Autonomy:Works under general direction.Work is guided by objectives of the department or assignment.Refers to technical standards, principles, theories and precedents as needed.May set project timeframes and priorities based on project objectives and ongoing assignments.Recognizes and escalates problems. Contribution:Contributes to the work of group/team by ensuring the quality of the tasks/services provided by self.Contributes to the completion of milestones associated with specific projects or activities within own department or workgroup.Provides training/guidance to others and acts as a technical/scientific resource within work group/team.Establishes working relationships with others outside area of expertise.Minimum Requirements:MSc degree or BSc degree in Pharmaceutical/Life Sciences or related field or the equivalent combination of education and/or experienceTypically 1+ years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review and investigations.Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases.Experience with Manufacturing and/or Quality analytical processes and operations.Fluent in English language Let op: vacaturefraudeHelaas komt vacaturefraude steeds vaker voor. We waarschuwen je voor mogelijke misleiding:* Wij zullen nooit via WhatsApp of in een videogesprek vragen om jouw persoonlijke gegevens (zoals een kopie van je ID, bankgegevens of BSN).* Twijfel je over de echtheid van een vacature of contactpersoon? Neem dan altijd rechtstreeks contact met ons op via de officiële contactgegevens op onze website. Important: job fraud Unfortunately, job fraud is becoming more common. Beware of such scams:* We will never ask for personal information (such as a copy of your ID, bank details, or social security number) via WhatsApp or during a video call.* If you're unsure whether a vacancy or contact person is legitimate, please reach out to us directly using the official contact details on our website.Sourced from LinkedIn. Relocantly aggregates public job postings; apply on the original site.