Chefe de site, garantia de qualidade

- Responsible for directing the quality assurance / quality control processes and ensuring
compliance with the local / European government regulatory authorities, ISO 13485 / ISO 9001
Quality System Standards, MDD / MDR and other applicable regulations.
- Management of the Quality Management System, including Supplier Qualification, Internal
Audit programmes, Customer and Supplier Complaints, Non-conformances, CAPAs, Change
Control.
- As part of the Senior Management Team, I am responsible for ensuring that key performance
indicators (KPIs) are developed and escalated to the CEO / CFO and Site Manager.
- Provide technical direction, support and guidance for projects, qualifications and validations.
- Manage the activities and performance of a team of eleven Quality Technicians, Quality
Control Analysts and one Quality Manager, all reporting directly to this position. This includes
recruitment activities, training, people development, performance appraisals and performance
management issues.
- Ensure a state of inspection readiness and meet business objectives.
- Interface with auditors from regulatory agencies and customers.
- Develop action plans, initiate, and employ training/development programs and assignments to
further enhance technical skills and overall competencies of staff members.
- Responsible for implementing KPIs in the quality assurance processes and develop effective
strategies to ensure the continuous improvement and effectiveness of the quality system. 

- Provide leadership and direction to the companies Microbiology Functions.
- Subject matter expert on all aspects of environmental contamination control.
- Ensure that raw materials and products are tested within a timely manner, in accordance with
SAP lead times.
- Ensure that Environmental monitoring is performed to an appropriate level, and
commensurate to the activity being performed in the relevant areas.
- Drive Quality Improvement initiatives.
- Participate in regulatory submissions and variations
- Participate with the Regulatory Affairs Manager on regulatory projects to bring previous
submissions in to compliance.
- Ensure change controls, CAPAs, non-conformances and customer complaints are managed
with full compliance to company SOPs.
- Review and authorise company documents e.g. SOPs, Specifications, Validation Protocols
etc. on behalf of the Microbiology function.
- Assist in the company internal audit program
- Lead audits of Contract Research Organisation performing outsourced Microbiological
activities on Martindale Pharma’s behalf.
- Perform internal and external audits.
- Represent the department in internal/external quality audits. Ensure timely implementation of
resulting improvement recommendations or compliance gaps.
- Ensure that the Microbiology Functions are aware of any changes to legislation, guidelines
etc. as issued by the British/European Pharmacopeia, MHRA, Eudralex etc.
- Meet the relevant obligations of the Health and Safety at Work Act.
- Provide metrics on individual sections and team performance.
- Represent the Quality Control department during client and regulatory audits.
- Ensure a satisfactory and influential working relationship with key internal and external
customers.
- Provide an effective material, component and product testing service, complying with all
regulatory requirements and the needs of the broader business.
- Effective /efficient involvement in planning and organising of work, meeting all commitments.
- To work with line management and peer groups to deliver quality improvements.
- To support line management to meet the company objectives, such as KPIs.
- To work within multidisciplinary teams as required by the business.
- Build strong and long-term relationships with both internal and external stakeholders.
- Responsible for meeting customer commitments by ensuring resources supplied are utilised in
a cost effective manner to meet the agreed delivery requirements.
- Ensure departmental reports are provided in a clear, concise and timely manner.
- Presentation and interpretation of trending reports and graphs for specific functions as
required by internal customers
- Responsible for communicating, interpreting and implications of trending results obtained, with
senior staff
- Assist with the optimisation of processes and procedures
- Participate positively in reviews to improve effectiveness and efficiency.
- Manage resources to maximise department’s effectiveness and efficiencies.
- Provide employees with appropriate training, motivation and coaching development to achieve
effective performance standards and personal growth.
- Overall Responsibility for planning, assigning and directing of work including: appraising
performance, rewarding and disciplining employees and addressing complaints and resolving
problems.
- Responsible for interviewing, hiring and training employees within the department.
- Responsible for the financial management of the department, including setting goals for direct
reports.
- Develop and implement adequate and visible measures that are linked to continuous
improvement and that demonstrate the success of projects implemented.
- Develop and deliver budgets enabling Martindale Pharma to achieve continual improvement
in performance. 

- Oversee the testing and control of incoming raw materials and consumables to maintain
product quality.
- Oversee the microbiological testing of manufacturing facilities and finished products to
maintain product quality.
- Managing a team of 12 direct reports split between two manufacturing sites.
- Support manufacturing operations as sterility assurance expert to ensure compliant a
successful ongoing operations.
- Perform and train all manufacturing QC procedures, through understanding of cleanroom
contamination control and monitoring and EU GMP Guidelines.
- Support new client collaborations to ensure smooth and compliant new product introductions.
- Implement new systems and ways of working to improve efficiency where possible and to
maintain compliance.
- Lead the Quality Control Department and represent the department during interfaces with
other internal departments.
- Manage a team of microbiologists and chemists to ensure all testing to support product quality
is performed on time.
- Plan and assign work to achieve the most efficient use of personnel and resources.
- Set individual/team objectives, and perform informal and formal performance reviews of team
members and motivate via coaching, training and development.
- Develop junior staff with a view to succession planning.
- Communicate effectively and clearly to both internal and external customers/departments, and
support all arguments with sound scientific fact.
- Advise senior managers and other departments on matters of compliance as sterility
assurance expert.
- Provide constructive feedback to the team and other Oxford Biomedica departments.
- Represent the Quality Control department during client and regulatory audits.
- Authorize technical documentation and routinely participate in Batch Release procedures in
relation to the team’s activities.
- Application/improvement of Lean/Six Sigma Tools 

- Direct people management responsibilities, ensuring that all KPI’s, targets and any other
deadlines are met individually and by the team.
- Manage and process all HR and departmental documentation for the team members including
attendance sheets, overtime forms, sickness related documents, absence request forms and
annual leave and staff appraisals including 1:1s, probationary reviews and PMRs.
- Ensure compliance with company policies and procedures and internal and external Health
and Safety and Environmental Standards.
- Lead and drive the team to achieve the required business standards in terms of quality, safety
and KPI’s.
- Ensure that the training and development of the team is fully delivered, understood and
evidenced in line with both day to day and Company requirements.
- Organize the Team’s activities, to perform routine laboratory procedures, and to oversee
laboratory work within the team.
- Authorize technical documentation and routinely participate in Batch Release procedures in
relation to the team’s activities.
- Application/improvement of Lean/Six Sigma Tools
- Deputise for the QC Manager in their absence.
- Supervision and training of employees.
- Represent the Quality & Technical Services team at project team meetings and provide expert
technical advice.
- Represent the Quality and Technical Services team with external contractors involved with
design and build of new production facilities and/or processes as required.
- Ensure all activities follow standard operating procedures and/or protocols and, where
appropriate, are performed in compliance with GxP.
- Independently design, plan and manage own studies 
- Represent the company at external seminars and supplier visits.
- Input into the formulation of budgets related to projects and department.
- Work with other departments to resolve issues and implement corrective actions.
- Maintain and develop state of the art knowledge applicable to existing and future processes
and maintain up-to-date knowledge on regulatory expectations.
- Ensuring that all interactions and engagements are carried out with the highest ethical and
professional standards and that all work is accomplished with quality and in accordance with
the company values.
- Carry out other reasonable tasks as required by the QC Manager.
- Collaboration in various areas like Quality, Validation, Production and Engineering.
- Planning procedures and microbiological assays to the medicinal drugs produced in the
facilities.
- Responsible for monitoring procedures to assess the microbiological quality of medicinal
products and process production.
- Responsible for Environmental monitoring; trending, planning and report generation.
- Responsible for planning and execution of sterility testing, validations, cleaning validations,
total viable counts and plate reading. Validation reports generation.
- Responsible for delivering projects to reduce the risk of microbial contamination within
manufacturing processes in line with relevant regulatory legislation.
- Responsible for lead Out of Specification Investigations, Root Cause Analysis, Microbiology
Risk Assessments and implementation of appropriate corrective/preventative actions.
- Trends in environmental monitoring, microbiological purified water quality and microorganism
identification.
- Responsible for providing training in sterility environment; aseptic gowning, personnel training
and qualification.
- Participation in Audits and Inspections. Laboratory Deviations investigations and CAPA
implementation.
- Responsible for the generation of Quality Control Department SOP's. 

- Act as scientific interface between BTG and 3rd parties for technical discussions surrounding
the development of new scientific techniques.
- Supervision and training of employees
- Represent the Quality & Technical Services team at project team meetings and provide expert
technical advice
- Represent the Quality and Technical Services team with external contractors involved with
design and build of new production facilities and/or processes as required
- Perform routine duties in the laboratory in order to ensure the timely generation of accurate
data and information
- Ensure all activities follow standard operating procedures and/or protocols and, where
appropriate, are performed in compliance with GxP
- Independently design, plan and manage own studies
- Represent the company at external seminars and supplier visits
- Input into the formulation of budgets related to projects and department
- Work with other departments to resolve issues and implement corrective actions
- Maintain and develop state of the art knowledge applicable to existing and future processes
and maintain up-to-date knowledge on regulatory expectations
- Ensuring that all interactions and engagements are carried out with the highest ethical and
professional standards and that all work is accomplished with quality and in accordance with
BTG values
- Carry out other reasonable tasks as required by the QC Manager
- Collaboration in various areas like Quality, Production and Engineering
- Planning procedures and microbiological assays to the medicinal drugs produced in the
facilities
- Responsible for monitoring procedures to assess the microbiological quality of medicinal
products and process production 
- Responsible for Environmental monitoring; planning, execution and report generation
- Responsible for planning and execution of sterility testing, validations, cleaning validations,
total viable counts and plate reading. Validation reports generation
- Trends in environmental monitoring, microbiological purified water quality and microorganims
identification.
- Responsible for providing training in sterility environment; aseptic gowning, personnel training
and qualification
- Participation in Audits and Inspections. Laboratory Deviations investigations and CAPA
implementation
- Responsible for the generation of Quality Control Department SOP's 

- Collaboration in various areas like Quality, Production and Maintenance
- Planning procedures and microbiological assays to the medicinal drugs produced in the
facilities
- Responsible for monitoring procedures to assess the microbiological quality of medicinal
products and process production
- Responsible for Environmental monitoring; planning, execution and report generation
- Responsible for planning and execution of sterility testing, validations, cleaning validations,
total viable counts and plate reading. Validation reports generation
- Trends in environmental monitoring, microbiological purified water quality and microorganims
identification.
- Responsible for providing training in sterility environment; aseptic gowning, personnel training
and qualification
- Training and assessment of analysts
- Responsible for the technical coordination of the microbiology laboratory activities
- Responsible for assigning tasks and defining work objectives for the Microbiology Lab
Analysis
- Guidance and leadership of the laboratory team (2 people), rationalizing the distribution of
work in order to improve productivity and reduce response time
- Participation in Audits and Inspections. Laboratory Deviations investigations and CAPA
implementation
- Responsible for the generation of Quality Control Department SOP's
- Responsible for equipments, internal and external verifications
- Support the Qualified Person/QC Director, working as her backup in most tasks, regarding
Product release 

- Planning, development and implementation of production process from recombinant protein in
bioreactor
- Interpret and analyse experimental results and reports generation
- Operate bench and pilot scale fermentation systems
- Ensure that equipment is correctly maintained and controlled.
- HPLC practices and Knowledge’s
- Planning and execution of activities in the Molecular Biology Department
- Process development of animal cell culture in bioreactor
- Training and orientation of trainees
- Meetings with International Clients
- Client’s Reports elaboration and consultancy activities
- Process Support until the scale-up in CMO’s companies
- GMP experience 

Master Degree

Degree