Industry Pharma/Biotech/Clinical ResearchWork Experience 4-5 yearsCity CorkState/Province CorkCountry 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:
This position reports to the Process Validation Managerand is responsible for multi-modality process validation activities in a cGMPenvironment. This position will coordinate and manage process validationprojects related to the implementation of new manufacturing processes andchanges to existing processes according to the three phases of processvalidation. Process validation activities may include drug substancemanufacturing processes, drug product filling processes and completion ofvalidation risk/impact assessments and evaluations, etc.
The position organizes and performs process validationactivities with general supervision within a cross-functional cGMP environmentwhile fostering a collaborative Team environment. Other responsibilities ofthis position include project management, protocol generation, protocolexecution, final summary report generation, CTD module generation and review,and other duties as assigned.
Requirements
Responsibilities:
Perform process validation activities related to drug substance and drug products, throughdefined clinical and commercial stages.
Execute (protocol generation, execution, and finalpackage preparation) process validation activities related to theimplementation of process changes and new processes while exercising supervisedjudgment within broadly defined procedures and practices to establishacceptance criteria, and to identify and implement solutions to meet HealthAuthority requirements.
Assist with preparation of regulatory filings, withanswering questions from regulatory agencies, and with presentations ofmaterials during regulatory inspections/partner audits.
Development and implementation of SOPs/Guidelinedocuments with systemic procedural improvements.
Determine methods and procedures on new assignments withsupervision and in accordance with developed practices and procedures.
May participate on sub-teams.
Gain/maintain knowledge of industry standards andregulatory requirements for products developed and manufactured by client,validation techniques/approaches and systems utilized
Participate in multi-departmental meetings & projectteams.
Identifies and assists with implementation ofimprovements to Process Validation systems (department level impact).
Generation of process validation master plans, corevalidation master plans and additional supporting documentation.
Coordination of process validation activities performedat multiple locations including contract laboratories, contractmanufacturing/testing facilities and internal laboratories.
Coordination of process validation activities involvingcross-functional, multi-departmental teams including Manufacturing, TechnicalDevelopment, Quality Control, Quality Assurance, Regulatory Affairs, andothers.
Other duties as assigned
Education:
Bachelor of Arts/Sciences (BA/BS) degree, or higher, in atechnical discipline (physical, engineering, chemical or biological sciences)is required.
Training in project management is preferred
Experience:
2+ years experience in a cGMP regulated manufacturingenvironment, with exhibited knowledge or proficiency in process validation,process sciences and change control.
Organizational and management skills to participate inmulti-discipline project groups
Ability to communicate with, present data to, and defendapproaches in front of variable hierarchical audiences, scientific disciplinesand health authority reviewers/inspectorate.
Ability to comprehend scientific/technical informationrelated to equipment, processes, and regulatory expectations.
Understanding and demonstrated knowledge of regulatoryrequirements, guidelines, and recommendations for process validationexpectations.
Proficiency with technical writing expected.
Proficiency with standard office software applications,including MS Word, MS Excel, MS Project, MS Power Point. Experience andproficiency with other applications is highly beneficial.
This function will perform majority of work in an officesetting, reviewing documents, participating in meetings, authoring documents.This function may perform up to 60% of its functions at a computer terminal.
The work environment characteristics described here arerepresentative of those an employee encounters while performing the essentialfunctions of this job. Reasonable accommodations may be made to enableindividuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee isoccasionally exposed to work near moving mechanical parts; fumes or airborneparticles; toxic or caustic chemicals; high pressure and temperature utilitysystems, risk of electrical shock and vibration. The noise level in the workenvironment is usually moderate.
The ability to perform gowning activities and enter themanufacturing plant is preferred, but not required.
Equipment:
This position requires ability to utilize a computer toperform tasks.
Contacts:
This position will require interaction with multiplelevels (from technicians up through Sr. Management) in Quality Assurance,Quality Control, Corporate Compliance, Manufacturing,Technical Development,Facilities, Regulatory Affairs, and People Resources.
Scope:
The candidate will have a significant role in theapproval of documentation and support for release of manufacturing systems andprocesses for cGMP use. This position is required to successfully completeprojects in a timely manner supporting company goals and objectives. Decisionsmade by this position can significantly affect project timelines and theability to manufacture drug substance/drug product meeting Health Authorityrequirements.
Demonstrated proficiency and experience in developing andmaintaining validation department within cGMP expectations for the manufactureof drugs.
Demonstrated proficiency and experience in maintainingand defending validation systems satisfying regulatory inspection scrutiny
Demonstrated proficiency and experience in managingprojects requiring multi-departmental coordination.
Demonstrated experience and knowledge ofmulti-departmental functions and issues (understanding the organization).
Successfully achieving project goals and meeting companydeadlines in timely and cost-effective manner.
#J-18808-Ljbffr