QC Section Head

Reporting to the Head of Quality you will lead and manage the workload and performance of the QC Department ensuring the successful and compliant delivery of team goals, positive KPI improvement and sustainment, whilst maintaining robust Laboratory Management Systems and adhering to regulatory compliance and expected batch release timelines in support of customer expectations.

• 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

• 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.