About PSC Biotech Who are we?PSC Biotech is a leading Biotech Consultancy firm founded
in 1996, headquartered in Pomona, California, USA, with Global operations in
Ireland, India, Singapore, Australia and the US, serving 350 clients in more
than 23 countries worldwide. We provide cloud-based software solutions for
Quality Management and Regulatory Inspections, pharmaceuticals contract
manufacturing professionals, and metrology services to our clients. ‘Take your Career to a new Level’PSC Biotech disrupts the conventional consultancy model
by aligning our EVP as one of the unique selling point which includes the
opportunity to work with the most talented cohort of like-minded professionals
operating in the Pharma/ Biotech Industry. We offer a permanent contract of
employment giving exposure of working in Top Pharmaceutical client sites in a
diverse-cultural work setting. Employee Value PropositionEmployees are the “heartbeat” of PSC Biotech, we provide
unparalleled empowering career development though Learning & Development
in-house training mentorship through constant guidance to facilitate career
progression. We believe in creating high performing teams that can exceed our
client’s expectations with regards to quality of all scalable and business unit
deliverables, staying under budget and ensuring timelines for our deliverables
are being met. Overview:The Quality Specialist – Quality Systems supports the
Quality Systems activities in the both the Drug Substance and Drug Product. The
Quality Specialist participates as a member of the Quality Systems Team.RequirementsRole Functions:The incumbent ensures timely and effective completion of
the Quality Systems core functions in accordance with schedules and policies,
procedures and guidelines, including;Sub System Ownership:Complete sub system ownership responsibilities as per the
site System Ownership list. Quality SME for Process, Cleaning, Water, Equipment:To provide leadership, through knowledge and skill
regarding the validation standards required for a Drug Substance and Drug
Product (SDI & OSD) pharmaceutical facility.Includes participating in and supporting the site PVC
(Process Validation Committee), WVC (Water Validation Committee), CVG (Cleaning
Validation Group),) and Equipment Qualification Validation Committee (EQVC).Approval of all validation documentation and ensuring
compliance to policies, procedures and guidelines. Ensures that validation
status is maintained following changes/modifications.Supports the implementation of site or capital projects
by defining validation requirements and providing technical assistance and
support as a member of the project teams.Develops Validation Summary Reports and assist in
developing overall Quality plans for major projects.Works with other areas in industry to predict future
trends in validation and to determine best practice.SAP Quality Process StewardQuality SME for Change Control:Principle Quality contact for all site change requests
(with impact on processing) – Provide Quality and change analyst review for all
change requests through all the stages of the change control process ensuring
compliance and site policies, procedures and guidelines.Principle Quality contact for all Quality assessment of
material control strategies associated with change requests for processing and
analytical changes.Laboratory QA oversightSupport and approve the systems supporting laboratory
functions, instrumentation and GLIMS. Provide Quality oversight and approval
for laboratory incidents / investigations and documentation.Stability oversight: Review and approval of stability
reports (Intermediate and API stability data and reports are reviewed for
accuracy and to support OOS and investigations as appropriate).Microbiology Point of Contact. Knowledge of microbial
requirements in the pharmaceutical industry, to liaise with site Microbiologist
for all microbial issues eg water, utilities, environment, excipient or product
and as necessary. Quality Agreement System Management:Manage the site inventory of Quality Agreements to ensure
Quality Agreements are raised for all required relationships. Interact and
communicate with SD&PM, relevant stakeholders and external parties to
ensure appropriate Quality Agreements are current, approved, on file and
retrievable. Annual Review System Management:Manage the system ensuring that Annual Reviews
(AR/APR/PQR) for products and systems incl automation, are completed to meet
the Annual Review schedule.Creation, review and approval of Site Quality
documentation including:Site Master File, Validation Master Plan, policies or
procedures.Quality Oversight of site application User Access ReviewsApproval of all designated user access reviews, ensuring
compliance with site and policies and procedures.Quality Council:Manage the annual quality council schedule.Manage the monthly quality council agenda, minutes and
action follow up. Supplier Change Evaluations - Quality Role:Review and approve Supplier Change Evaluation
documentation.Complete/Approve MDS updates post SCE approvalApprove Supplier Transparency update change requests post
SCE approvalGenerate quality / technical agreements with suppliers as
appropriate. Supplier and Customer complaints:Participate in the investigation and review of any
internal / external customer complaints in accordance with agreed lead-times.Participate in the investigation and review of any
supplier complaints in accordance with agreed lead-times. Filing & Licence maintenance and Regulatory
Requests follow ups:Review and ongoing maintenance of site licences.Provide site documentation to support product filings in
accordance with CMC requests. QA Regulatory Data:Review and verify documentation that may be used for
submission to Pharm - CMC or other requester(s) for regulatory
submissions/filings. Assure the accuracy and integrity of all data and
information through a timely review program. Returned Goods:Manage the segregation and disposition of all returned
goods. Audit program:Support the internal GMP walk-down and scheduled audits
program.Support hosting of site Regulatory Inspections. Special Features:The incumbent operates as part of self-directed team in
carrying out day to day functions and assigning priorities.The incumbent monitors appropriate performance metrics to
ensure that the CoE delivers on all responsibilities in line with business
needs.On assignment, the incumbent participates in departmental
initiatives on improved compliance, and quality systems and participates in
cross functional interdepartmental teams.The incumbent must be assertive with excellent
communication skills, who can develop cross functional relationships and
network outside the plant.The incumbent promotes GMP awareness at the site.Validation principles and guidelinesUnderstands key business drivers and uses this knowledge
to make decisions and prioritiseSystem Development Life Cycle Business:The Specialist must demonstrate the core values and
behaviours.The Specialist must possess a high standard of knowledge
and skills in the following areas:Computer Applications: Word, Excel, Access, eLogs, File
and Email Management.Meetings ManagementTechnical report writingTime managementAnalytical Problem solving skills applied to issue
identification and resolutionContinuous improvement skills:Responds to non-standard requestsSupports cross functional investigationsTimely decision makingInclusion behaviours Leadership:Strong Communication skills both written and oral
including persuading othersPro-active approachPlanning and schedulingBrainstorming/Ideas generation - tools and techniquesCustomer serviceInterpersonal SkillsFacilitation skillsInterpersonal Team membership and leading Skills eg.
Listening, integrating diverse perspectives, adds value to the achievement of
team goals. Qualifications:Minimum of Degree or post-graduate qualification in
Science, Pharmacy or Engineering field#LI-AP1