- Performdistributor Audits and progress QTAs with distributors
- Provide Quality Operations support to approved vendorsand ensure that any risks are communicated effectively
- Review pharmaceutical product batch files for timelyrelease by Responsible Person (RP) Responsible Person forImportation (RPi) or certification by Qualified Person(QP)
- Provide QA support to the business duringroot cause analysis investigation
- Raise onrequest or using own initiative Third party notification CAPA GDPissues Deviation and Change Control
- Supportactivities required to effectively maintain the companyPharmaceutical Quality System
- Monitor alertsfor potential overdue for Complaints CAPA GDP issues Deviation andChange Control
- Compliant review of batchdocuments in preparation for QP RPi or RP release
- Completion of assigned Quality and Technical Agreementsto eliminate any overdue
- Track and follow upon all outstanding assigned Quality and TechnicalAgreements
- Participate in internal andexternal audits
- Participate in reviews of OOSand RCAs in a timely manner with timely escalations to HOQ/QP asrequired
- Work with relevant stakeholders toachieve timely completion of all CAPAs relating to Customer andInternal Audit audits
- Ad hoc quality supportcommunication of risks and other tasks asassigned
- Candidates withproven relevant experience gained within a pharmaceutical qualitydepartment are likely to have the skills required to be successfulin this role. We are also looking for:
- Bachelors degree in Pharmaceutical Science orequivalent
- Postgraduate degree or diploma isdesirable
- Great IT skills including MSsoftware/programs
- Experience gained inmanufacturing API solid dosage forms liquids creams and sterileproducts
- Experience of facilitating OOS andRoot Cause Analysis
- Routine preparation ofQuality and Technical Agreements
- Good workingknowledge of current GMP SOPs EU GMDP and ICH guidelines andregulations
- Previous auditing experience wouldbe an advantage
- Excellent time management andorganisational skills with demonstrated ability to juggle multiplecompeting tasks and demands
- Ability to worksuccessfully within crossfunctional teams as well asindependently
- Excellent professionalcommunication skills both written andverbal
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Quality Specialist - Basildon, United Kingdom - Lifelancer
Description
About therole:
Reporting to the QualifiedPerson (QP) you will be a key member of the team which isresponsible for providing a quality support to the Quality SystemsOperational Quality and Technical Qualityteams.
Our Quality Department has an ethos ofcontinuous improvement refining systems and creating efficiencies.This along with the rapid growth of the business leads to a variedand dynamic workingenvironment.
Main responsibilitiesduties:
Aboutyou:
Please use the below link forjob application and quickerresponse.
RemoteWork :
No
