* Industry Pharma/Biotech/Clinical Research
* Work Experience 4-5 years
* City Dundalk
* State/Province Louth
* Country Ireland
Job Description
About PSC Biotech
Who are we?
PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.
‘Take your Career to a new Level’
PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.
Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient’s expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.
Overview:
The Quality team have a great opportunity for a QualityAssurance Specialist.QA CSQ/CQV specialist, will be reporting to the QACSQ/CQV Lead. This role is responsible for oversight of all validationactivities ensuring compliance with current regulatory requirements, cGMP andcompany SOPs. It includes validation/qualification activities for facilities,utilities, equipment, computerized systems, cleaning, processes, storage areas,controlled temperature units (CTUs) and shipping. An important aspect of thisrole is provision of QA oversight to the Commissioning, Qualification andValidation (CQV) activities associated with the Facility start-up project andsupporting the transition from project phase through to sustaining phase withrespect to validation activities
Requirements
Job Responsibilities:
* Ensure the quality oversight of thequalification/validation activities of all facilities, utilities, equipment,computerized systems, cleaning processes, manufacturing processes, storageareas, controlled temperature units (CTUs) and shipping processes.
* Ensure that all validation documentation and associateddata, including but not limited to; plans, URSs, quality risk assessments,protocols, and reports, are reviewed and approved by QA for conformance toSOPs, specifications and other applicable acceptance criteria.
* Ensure that all events/deviations, investigations, andchange evaluations that occur during qualification/validation activities haveappropriate QA oversight, QA review and approval and adhere to SOPs and cGMPrequirements.
* Review SOPs relating to qualification/validationactivities.
* Provision of support in Regulatory inspections and Clientaudits.
* Provision of QA Validations expertise to maintainvalidation status of the facility.
* Maintain an understanding of cGMP regulations andguidance in relation to all aspects of validation and/or qualification offacilities, utilities, equipment, computerized systems, cleaning processes,manufacturing processes, storage areas, controlled temperature units (CTUs) andshipping processes.
* Coordinate all QA Validations activities to ensureschedule adherence and on time delivery of project deliverables.
* Manage and develop the QA Validations team including, butnot limited to, activities such as performance management, recruitment, andtraining.
* Other quality activities as needed and assigned.
Education and Skills Required:
* B.Sc or B.Eng in a Scientific or Engineering relateddiscipline (e.g. biochemistry, chemistry, engineering).
* 4-5 years experience in a Quality Engineering/QualityAssurance/Quality Validations role for Biologics or related pharmaceutical/medical device manufacturing in a FDA/ EU regulated environment.
* Thorough understanding of the validation requirementsassociated with a cGMP manufacturing facility
* Strong technical aptitude is required.
Special knowledge:
* Deep knowledge of GxP regulations applicable to biologicsmanufacturing (e.g. EU-GMP, FDA, ISO) and the industry standards applicable tovalidation, including but not limited to; GAMP, ISPE, ISO, ASME and BPE.
* Knowledge of trouble shooting and problem-solving skills.Knowledge of formal root cause analysis methods and tools such as Ishikawadiagrams, FMEA etc.
Skills:
* Independent and self-motivated.
* Able to multi-task in fast-paced, dynamic workingenvironment.
* Strong planning, organisational, and time managementskills.
* Critical thinking skills.
* Able to operate across functional boundaries, bothinternal and external.
#J-18808-Ljbffr