Manager
1 month ago
About PSC Biotech
Who we are?
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.
Role Description:
Reports To: Laboratory Systems Leader/ Laboratory Leader
Job Purpose: To execute and appropriately document testing of Raw Materials, Intermediates, Drug Substance & Drug Product in accordance with Analytical Standards and/or other approved protocols. To provide analytical support to product quality investigations including the use of sophisticated analytical techniques. To undertake significant assignments and to work on own initiative and with minimum supervision e.g.technology transfer for new product demonstrations; new methods development; management of an on-going programme such as the Intermediate Stability programme; and to provide training for other chemists and other lab staff
RequirementsRole Functions:
1. The Laboratory Analyst has responsibility for Raw Material, Intermediate, Drug Substance & Drug Product testing to meet compliance requirements and customer targets. The Analyst may also take a leadership role in change or improvement projects in ADC or at a site level.
2. The Laboratory Analyst is responsible for ensuring all testing activities comply with cGMP. The Laboratory Analyst assures compliance with all safety and environmental requirements. Compliance with other regulated areas such as HR policies are also responsibilities of the role.
3. To test Raw Materials, Intermediates, Drug Substance & Drug Product in accordance with Analytical Standards and/or other approved protocols.
4. To comply with all GMP and analytical procedures relevant to area of work.
5. To adhere and comply with department High Performance Analytical Behaviours
6. To document all testing activities and to input results into computerised lab systems in accordance with department and MMD standards.
7. To provide analytical support to product quality investigations and new product demonstrations under the supervision of the Laboratory Leader or designate.
8. Complete the investigation of laboratory OOSs (Z1 Quality Notifications), in line with site and divisional procedures, and Provide leadership in the laboratory aspects of OOS investigations.
9. Complete documentation checks (e.g. GCM s, Quality Notifications, Data Integrity) as required for test packages prior to release.
10. To complete testing as required on non routine samples to support process changes, Request for Service, Quality Notifications
11. Accountable for own laboratory safety practices. Follow the principles of Safe by Choice
12. To provide lead analytical support to product quality investigations and new product demonstrations using own initiative and with minimum supervision.13. To identify and aid resolution of analytical issues within the IPT laboratory.
14. To be a resource for analytical testing for the site as required.
15. Execute specific assignments (e.g. DI Initiatives, Lab X Champion, Empower/LIMS Superuser and other systems) in a comprehensive manner and under minimum supervision.
16. Complete training with new laboratory Analysts and Laboratory Apprentices.
Core Competencies:
Technical:
To have demonstrated knowledge of MMD and site quality policies, procedures and guidelines
which relate to finished product testing and release.
Relevant GMP standards
Lab safety standards
Business:
To perform analytical testing with a high degree of precision and accuracy
To perform instrument maintenance and troubleshooting
To maintain accurate records in compliance with ALCOA principles and GMP expectations
To understand and internalise procedures relevant to GMP operations
To communicate clearly and concisely on technical issues
On assignment, to manage specific department projects
To provide training programmes to laboratory staff as assigned
To liaise effectively with external groups such as MRL, RAS, DI COE, etc.
To act as auditee (in internal and external audits) for assigned areas of responsibility
Leadership:
Technical lab skills (precision, etc)
Strong aptitude for handling analytical instruments
Clear understanding of DI requirements
Mechanical and computer
Communication - written, oral
Team and interpersonal skills
Leadership skills
Special Features:
- On assignment, and depending on experience, participates in or leads departmental initiatives on improved compliance and quality systems.
Operates as part of self-directed team in allocating testing and assigning priorities.
Educational Requirements:
- Minimum of BSc in Chemistry or related discipline.
#LI- AM1
Role Functions: 1. The Laboratory Analyst has responsibility for Raw Material, Intermediate, Drug Substance & Drug Product testing to meet compliance requirements and customer targets. The Analyst may also take a leadership role in change or improvement projects in ADC or at a site level. 2. The Laboratory Analyst is responsible for ensuring all testing activities comply with cGMP. The Laboratory Analyst assures compliance with all safety and environmental requirements. Compliance with other regulated areas such as HR policies are also responsibilities of the role. 3. To test Raw Materials, Intermediates, Drug Substance & Drug Product in accordance with Analytical Standards and/or other approved protocols. 4. To comply with all GMP and analytical procedures relevant to area of work. 5. To adhere and comply with department High Performance Analytical Behaviours 6. To document all testing activities and to input results into computerised lab systems in accordance with department and MMD standards. 7. To provide analytical support to product quality investigations and new product demonstrations under the supervision of the Laboratory Leader or designate. 8. Complete the investigation of laboratory OOSs (Z1 Quality Notifications), in line with site and divisional procedures, and Provide leadership in the laboratory aspects of OOS investigations. 9. Complete documentation checks (e.g. GCM s, Quality Notifications, Data Integrity) as required for test packages prior to release. 10. To complete testing as required on non routine samples to support process changes, Request for Service, Quality Notifications 11. Accountable for own laboratory safety practices. Follow the principles of Safe by Choice 12. To provide lead analytical support to product quality investigations and new product demonstrations using own initiative and with minimum supervision.13. To identify and aid resolution of analytical issues within the IPT laboratory. 14. To be a resource for analytical testing for the site as required. 15. Execute specific assignments (e.g. DI Initiatives, Lab X Champion, Empower/LIMS Superuser and other systems) in a comprehensive manner and under minimum supervision. 16. Complete training with new laboratory Analysts and Laboratory Apprentices. Core Competencies: Technical: To have demonstrated knowledge of MMD and site quality policies, procedures and guidelines which relate to finished product testing and release. Relevant GMP standards Lab safety standards Business: To perform analytical testing with a high degree of precision and accuracy To perform instrument maintenance and troubleshooting To maintain accurate records in compliance with ALCOA principles and GMP expectations To understand and internalise procedures relevant to GMP operations To communicate clearly and concisely on technical issues On assignment, to manage specific department projects To provide training programmes to laboratory staff as assigned To liaise effectively with external groups such as MRL, RAS, DI COE, etc. To act as auditee (in internal and external audits) for assigned areas of responsibility Leadership: Analytical chemistry demonstrated ability in all technical elements relevant to IPT operation Technical lab skills (precision, etc) Strong aptitude for handling analytical instruments Clear understanding of DI requirements Mechanical and computer Communication - written, oral Team and interpersonal skills Leadership skills Special Features: On assignment, and depending on experience, participates in or leads departmental initiatives on improved compliance and quality systems. Operates as part of self-directed team in allocating testing and assigning priorities. Educational Requirements: Minimum of BSc in Chemistry or related discipline. #LI- AM1
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