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 Proposition
Employees 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:
* Performs QC assignments for quality systems, processes and controls.
* Accountable for contribution to ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety & reliable customer supply.
* Responds to Operational and business area's, ensuring compliance with cGMP and corporate regulations.
* Support the performance of the site cGMP activities.
Responsibilities:
* Comply with and execute CGMP/GDP in the performance of day-to-day business activities.
* Ensure data integrity principles: Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) are adhered to for records and data in day-to-day business activities.
* Attend and successfully complete applicable CGMP training.
* Escalate any potential violation of CGMP and/or other concerns which may affect the safety, efficacy, quality, or purity of human health products.
* Work collaboratively to ensure a safe and compliant culture
* Participate in driving a high performing & inclusive culture, stimulating personal growth & development.
* May be required to perform other duties as assigned.
Quality
* Liaise with the Quality/ Business Area Specialists/QC Leads) to resolve quality related queries where required.
* Ensure that adequate processes and procedures are in place and followed for all Quality activities.
* Where required work shift patterns in line with manufacturing operations to ensure Quality operations (including testing, delivery and or oversight) as required as per business needs & if needed.
* Provide support to the relevant support functions to ensure manufacturing and release of vaccine and biologic products activities, in compliance with applicable procedures, our Company's Global Policies and Guidelines, regulatory requirements and current Good Manufacturing Practices (cGMP).
* Develop and maintain effective cross-functional relationships with other departments and support functions to ensure that the process for the manufacturing,, testing and release of vaccine and biologic products are in compliance with cGMP and the associated regulatory requirements.
* Identify and support compliance initiatives to improve compliance status and overall operational efficiency for batch release at the site.
* Support business critical projects related to the Quality Department.
Delivery:
* Responds to standard requests and communication processes to allow the flow of appropriate information between departments.
* Use MPS principles and tools to identify and support continuous improvement by active participation to ensure quality systems and work practices are effective, efficient and ensure compliance and overall operational efficiency for batch and material release at the site where required.
* Acknowledge approved job description for the role.
* Support in resolving routine potential quality issues.
* Provide quality support of controls and procedures for the end to end material and product lifecycle where required.
Quality Control:
* Perform laboratory testing and / or materials inspections to determine specification conformance.
* Perform all required analytical, microbiological and control testing to support the site.
* Maintain an adequate, qualified and compliant laboratory environment to conduct testing while adhering to appropriate PPE and safety requirements.
Compliance Responsibilities:
* Execute/Review /Support deviation/ CAPA activities, complaints, data integrity, Material Qualification, Validation, Quality Risk Management processes and other documentation including generation, investigation, documentation, implementation, verification closure, effectiveness and supporting trending where required for the Quality department and supporting functions.
* Ensure compliance to regulatory requirements.
* Review of all manufacturing batch/ material documentation including (but not limited to) electronic batch records, real time reports, master data using the Quality (Control) systems where required.
* Review of, SOP's, GMP data and other documents as necessary for the Quality department where required
* Contribute to effective writing/revising/rolling out of accurate operational procedures, training materials and maintenance procedures for various Quality related systems.
Other:
* Participate in training programs & provide training to other team members as required.
* Provide quality support to the qualification/validation, technical transfers and commercial operations at the facility where required.
* Applies knowledge and skills to other areas within product/ department; may act as a source of technical expertise for others.
* Identifies and solves problems.
* Acknowledge approved job description for the role.
* Respond to and resolve routine potential quality issues by providing quality compliance guidance, expertise & critical thinking.
* Provide quality support to the qualification/validation, technical transfers, and commercial operations at the facility where required.
* Report on and assist with monitoring the Quality Management Systems. Generate reports for performance metrics and significant quality events & issues.
* Applies knowledge and skills to other areas within product/department ; provides technical guidance and training to others.
* Anticipates and solves complex production/operational problems.
* Participate in internal and external audits and inspections, ensuring department compliance/readiness.
Education:
* Bachelors Degree or higher preferred; ideally in a related Science discipline