Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials
Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
DESCRIPTION:
We operate a matrix management system to deliver key responsibilities. You are accountable for the management of a team of scientific officers who perform QC Chemistry analysis of incoming goods/in-process samples/intermediates/finished product samples.
Responsibilities:
- Act as first point of escalation for technical, compliance and personnel problem resolution
- To lead, plan, coordinate the routine team activities of the section to meet the needs of the business. The activities include (not fully comprehensive):
- Analysis of incoming goods/in-process samples/intermediates/finished product samples to Good Manufacturing Practice (GMP) standards
- GMP analysis of stability samples
- Completion, update and review of technical documentation (including analytical write ups, standard operating procedures, GMP forms, specifications, investigations and reports)
- Verification/calibration of lab equipment
- Maintenance of up-to-date training in-line with GMP expectations
- Management of QC chemical, reference standard and consumable stock levels
- To perform or coordinate QC batch release procedures and deliver lab throughput in-line with the business plan
- To manage and coordinate stability studies ensuring compliance with business procedures and ICH guidelines.
- To prepare, review or approve department technical documentation, as required including analytical and laboratory data for accuracy, completeness and compliance with documented procedures
- To maintain a thorough understanding of international regulatory requirements (cGMP, Good QC Lab Practice, pharmacopoeial monographs/chapters, ICH guidelines) pertinent to the Section, and ensure all work within the Section is compliant. Act as a Subject Matter Expert with regulators / clients (i.e. key part of audits and inspections)
- Manage and deliver projects within the Department
- To communicate effectively with others on site and internationally, and to participate with them in problem solving activities, as required
- Collaborate and coordinate initiatives with other QC Supervisors and Managers for improved compliance, efficiency, HSE, working conditions etc.
- Identify and drive Practical Process Improvement (PPI) initiatives
- Undertake/support Self-inspections, GEMBA walks and Huddle meetings
- Undertake ad-hoc activities that may be required by the business
- Support and encourage a “Quality Culture” and company 4i values throughout QC
- Deputise for the QC Manager in their absence
People Management:
- To build rewarding, successful work environments and provide support and mentorship to your team ensuring high levels of performance, whilst following company procedures to ensure the team is managed in an effective way
- To train others as required, to ensure that all section members are adequately trained, and appropriate training records are maintained
- To complete People Management tasks for your team including but not limited to: attracting and selecting new diverse talent, onboarding and training, setting clear goals and performance expectations, value inclusivity, providing open, timely and actionable feedback, conducting appraisals, setting an assessing the achievement of objectives, and development discussions.
- Be a role model for the 4i values: - Integrity – Intensity – Innovation – Involvement
EH&S:
- Understand emergency procedures and follow safe systems of work.
- Ensure compliance with environment, health and safety and security policies and procedures, rules, signage and instructions at all times
- Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules
Minimum Requirements/Qualifications:
- Relevant science-based degree; e.g. Chemistry, Biology, Pharmacy
- Substantial experience 5-10 years’ working in a pharmaceutical QC function, preferably within a sterile site
- Extensive experience of instrumental and traditional analytical techniques
- Extensive understanding of Data Integrity principles and practical implementation within laboratories
- 2+ years’ experience of team leadership (coordination or activities, absence management, conducting appraisals, problem resolution, motivation, coaching/mentoring etc…)
- Communication skills – verbal and written at both internal and external levels. Able to deliver presentations, facilitate meetings and trainings, and create reports
- Good collaboration and conflict resolution skills
- Ability to work in a fast-paced environment essential
- Proficient time management and project management skills to deliver to critical timelines whilst maintaining attention to detail.