Reporting the to Senior QC Technician you will provide effective and efficient Quality Control support to KD Pharma UK
KEY RESPONSIBILITIES:
- Overseeing and supporting the day-to-day running of the department and allocation of work.
- Ensure activities within the department are in line with company policy, best practice, and cGMP/GLP compliant.
- Produce results in line with company policy, best practice and cGMP in the desired timeframes as directed by the business and by their line manager.
- Facilitate review and approval of change control, OOS/OOT, and deviation records under their control.
- Overseeing Quality Control activities including.
o Batch Testing Management
o Incoming material QC and Release
o Inspection Readiness for all associated QC aspects
o Quality & SHE Risk Management within areas of accountability.
o GMP/SHE Training Compliance
o Input into Quality Management Review
o Regulations Compliance management for QC
o Quality Documentation Lifecycle management for QC
o Validation and Qualification activities for QC Labs and Equipment.
o Retain and Reserve sample management.
o Stability or Technical studies under QC control
o QC support for NPI and Technology transfer of any new/improved assays
- Hiring and day-to-day management of people for the QC department
- The ability to consistently perform and understand the tasks that are the responsibility of the QC Department.
- With support from the Head of Quality to instigate and manage projects to ensure the business continues to operate to cGMP/GLP.
- Successfully liaise with members of other departments at all levels to resolve any Quality related issues creating a partnership working environment under the 'Quality at Source' initiative.
- Create and Perform Lab related training.
- Liaise with internal and external customers / project managers on QC/Quality matters.
- Support resource planning and CAPEX for QC.
QUALIFICATIONS & EXPERIENCE:
- Scientific degree (ideally pharmacy, pharmaceutical sciences, biology, chemistry or related).
- Previous experience in a pharmaceutical or similar industry.
- Excellent first line management skills.
- Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
- Excellent verbal and technical writing skills with the ability to communicate at all levels.
- Computer literate in Microsoft Office (i.e. word, excel, outlook, PowerPoint).
- An excellent awareness of cGMP/GLP best practice and processes.
- The ability to take a leading role within the team and support a high performing quality/safety minded culture.
- Have excellent time management/organisational skills to perform their job efficiently; requires minimal input from line management to achieve planning/deadlines.
- Ability to suggest innovative and practical ideas/solutions to problems while using associated continuous improvement tools and techniques.
OTHER:
- Working in line with current company cGMP procedures including all relevant SOP's and guidelines.
- Ensuring that work is carried out in accordance with appropriate EHS Procedures.