Beschreibung
For our client in Stein we are looking for a Senior QA Compliance Expert for a 6 month contract.
Place: Stein
Duration: ASAP-31.12.2017
Workload: 100%
Job Purpose:
To plan and execute assigned GMP QA Compliance tasks related to the support of sterile manufacturing, such as: supporting qualification and validation activities related to routine manufacturing and launch projects, review and approval of GMP relevant documentation, Change Control, Deviation handling and representation of QA Compliance Qualification & Validation in dedicated project(s).
Major accountabilities:
Represent QA Compliance Qualification & Validation in relevant aspects eg in dedicated projects and commercial manufacturing
Review and approve Process Validation Protocols and Reports (Revalidation, Verification, Product Transfers) including associated Risk Assessments and Deviations
Review and approve Cleaning Validation Protocols and Reports (Revalidation, Verification, Prod-uct Transfers) including associated Risk Assessments and Deviations
Review and approve Equipment, Facility and Utilities Qualification Protocols and Reports includ-ing associated Risk Assessments and Deviations
Perform Quality risk assessments in case of critical deviations and initiate escalation process if applicable
As CCEx QA gate approver in Agile PLM system or Change Control QA in Trackwise AQWA system assess all changes for their QA relevance. As a CCEx Change Phase Manager in Agile PLM or Site Change Coordinator in Trackwise AQWA:
Lead the on-site and the inter-functional evaluation with the relevant experts and implementation phase of change requests, considering the most effective implementation strategy, priorities cGMPs, regulatory requirements, Corporate Quality Manuals, company's policies and cost effectiveness.
Ensure efficient, timely and clear communication to all involved partners (on-site and off-site incl. to global product life cycle leaser and DRA REG CMC) as required for flawless project execution.
Ensure timely delivery of compete and consistent source data to DRA REG CMC
Coordinate and provide timely review (on-site) of CMC documentation
Ensure that projects are realized/implemented without stock-out
Support process experts/product stewards/facilitators in evaluation, planning and execution for main and sub process (eg CAR, capacity planning, resources etc.)
Communicate project progress and deviations as appropriate. To elaborate risk mitigation plans as appropriate.
Review and approve Master Batch Records
Maintain relevant SOPs, support for GMP training
Support/Lead Self Inspections (as Lead auditor or Co-Auditor)
Support inspections by Health Authorities, customers etc.
Initiate and implement quality improvement projects
Train and onboard new members of the Team
Ideal Background
Education(minimum/desirable):
(Technical) University or academic degree in Chemistry, Biology, Pharmacy or equivalent
Post graduate diploma in business administration or equivalent
Sprachen: German/English spoken and written;
Erfahrung: Professional experience in Quality Control/Quality Assurance or in the manufacturing of pharmaceutical drug products and Steriles/Biotechnology
Profound knowledge of cGMPs
Technical/Professional Knowledge and Skills
Knowledge of the current pharmacopoeia requirements including technical methods (USP, Ph. Eur, JP, &)
Excellent communication skills with team members, peers and superiors; Coaches and inspires people to achieve team goals
Superior problem solving, decision making and planning skills as appropriate.
Sets clear priorities for task for him/herself and the team.
Excellent knowledge of GMP regulations
Ability to work under time pressure
Focus on customer satisfaction
Recognized expert; networking with CPL/QA/QC, PUs, TRD, HSE, RegCMC, SCM, etc.
Support PUs to guarantee high quality and current GMP
Provides new solutions for existing processes and is committed to continuous improvements
Assumes responsibility and sets clear priorities
Is a strong team player
Readily shares information and professional knowledge
Is a role model
Communicates on all levels within and outside own function
Works independently, efficiently and contentiously
Is committed to quality, GSU and GMP
Is goal-oriented and flexible
Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred) (see below) For further details feel free to call me
I am looking forward to receiving your application.