- Under minimal supervision, responsible for one or more of the following activities in QC including sample and data management and equipment maintenance.
- Contributes to team by ensuring the quality of the tasks/services provided by self
- Contributes to the completion of milestones associated with specific projects or activities within team
- This role will support QC and manufacturing operations, as such some extended hours and weekend work flexibility may be necessary as required.
Specific Job Duties:
- Support Stability Programme on site and frequent collaboration with global Stability Product Representatives (SPR) or Product Quality Leads (PQL) regarding all stability programme matters.
- Perform routine sample management tasks as per procedures.
- With a high degree of technical flexibility, work across diverse areas within QC
- Plan and perform routine tasks with efficiency and accuracy.
- Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of tasks.
- Report, evaluate, back-up/archive, trend and approve data.
- Troubleshoot, solve problems and communicate with stakeholders.
- Initiate and/or implement changes in controlled documents.
- Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
- Write protocols and perform validation and equipment qualification/ verification. Operate and maintain specialised equipment.
- Introduce new techniques/ Processes to the area, where appropriate.
- Evaluate sample management practices for compliance and operational excellence improvement on a continuous basis.
- LIMS data coordination of commercial and import testing on site where applicable
- May provide technical guidance.May contribute to regulatory filings.
- May represent the department/organization on various teams. May train others.
- May interact with outside resources.
- Perform general housekeeping in all sample management areas.
- Primary knowledge, skills, competencies and relevant experience
- Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories.
- Deepens technical knowledge through exposure and continuous learning
- Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
- Take initiative to identify and drive improvements
- Communication skills (verbal and written) at all levelsStrong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
- Presentation skills
- Escalate issues professionally and on a timely basis
Decision Making skills
- Teamwork and Coaching others
- Negotiation and Influence skills
- Investigation skills
- Problem solving skillsApplies research, information gathering, analytical, and interpretation skills to problems of diverse scopeEnsures compliance within regulatory environment
- Develops solutions to technical problems of moderate complexity
- Screens, categorizes, evaluates, reconciles, reports, and resolves data integrity issues
- Interprets generally defined practices and methods
- Able to use statistical analysis tools to perform data trending and evaluation
- Project Management and organizational skills, including ability to follow assignments through to completion
- Demonstrated ability to work independently and deliver right first time results
- Works under minimal direction Work is guided by objectives of the department or assignment
- Follows procedures
- Refers to technical standards, principles, theories and precedents as needed
- May set project timeframes and priorities based on project objectives and ongoing assignments
- Recognizes and escalates problems
- Working knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to colleagues
- Auditing documentation and operation process
- Demonstrated ability to interact with regulatory agencies
- Bachelor’s degree in a Science related field is required.
- 5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry, with a minimum of 2 – 3 years of specific sample management/ stability programme management experience.
- Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.