Overview:
Along with Quality Control Analytical Manager, manage from implementation to maintenance all activities related to CMO/CDMO new molecules.
Suitable day-to-day organization within area and designated technicians and analysts for CMO/CDMO Projects.
In coordination with Quality Control Manager, ensure of method implementation in Quality Control
**Responsibilities**:
- Plan, organize, and manage resources effectively to meet CMO/CDMO project timelines.
- CMO Projects follow up, using a suitable tool (i.e. projects, think cell..)
- Collaborate with clients in design, adjustment, implementation, transfer and validation of analytical methods
- Collaborate with MSAT in process validation protocols of new CMO molecules
- Validation and transfer activities of analytical methods from CMO projects
- Ensure the new methods are corrected implemented in QC commercial departments and give support to them when needed
- Control and archive documentation related to qualification and validation
- Overseeing analytical method validation, verification, and transfer activities in accordance with regulatory guidelines and company standards.
- Ensuring compliance with Compendial (USP, EP, JP) and ICH requirements for analytical methods.
- Assist in the preparation of quotations for projects.
- Assist in the preparation of budget related to CMO/CDMO projects. Suggest acquiring equipment and devices needed for new CMO projects.
- Management and execution of various stability studies according to GMP standards and procedures.
- Conducting investigations into complaints and deviations and reporting this to QA.
- Taking care of corrective and preventive measures in the event of complaints and deviations. Manage change control documentation and CAPA
- Participate in internal and external audits and regulatory inspections.
- Collaborate with Qualification and Validation personnel in design, adjustment, implementation and qualification of equipment to be used.
- Carry out activities for training required for personnel from QC CMO Projects.
- Constantly keep themselves updated on progress of EU and USA standards so as to keep GMP compliance updated.
- Provide help in start-up, qualification/validation of equipment involved in QC labs
- Provide technical support during audits (internal and external audits).
- Identification of needs and possibilities of improvement in area.
- Manage and use computerized systems of general management so as to issue and control documents and analytical records of their responsibility.
Qualifications:
- **Education**: Bachelor of Sciences
- ** Languages**:Fluent Spanish and English.
- ** Experience (years/area)**: > 5 years in the pharmaceutical / biotechnological industry in a similar role.
- **Specific Knowledge**:Biochemical, chemical and immunochemical techniques. Validations. Tech transfer. CMO/CDMO projects.
- ** Travels**: Available for sporadic travelling (1-2 a year).
- ** Personal skills**: Management of work teams, organization skills, customer oriented, communication skills, proactivity and flexibility.