Quality Control Manager

1 semana atrás

Loures, Portugal Hovione Tempo inteiro

Join a Market Leader:
Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market.

Our people are the main asset for our continued success. Reaching over 1950 team members, from 36 different nationalities, that are located across Asia, Europe and North America (Portugal, US, Macao, Ireland, China, Hong Kong, Japan, India, and Switzerland), including 4 production sites.

Working at Hovione means reaching for innovation and excellence in everything we do: for our clients, our partners and, above all, our patients. That is why we are In it for life.

You will be responsible to:
Defines and implements quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.
- Coordinate and supervise activities within the area and prioritize activities in case of conflict between simultaneous production lines / projects to ensure that the deliverables of each project are dealt in the team within the timeframes defined, with the appropriate quality and according to cGMP and that an outstanding service is provided to all customers (internal and external)
- Ensure that all TMs of the team have suitable training and qualifications to the work they perform
- Participate in client meetings, external and internal audits and Product/Project teams representing own area specialization
- Review and approve analytical test methods to be executed in own laboratory
- Review and approve reports prepared in own laboratory
- Check and approve raw material, intermediate and final product batches, stability samples, In Process and COL samples and/or all samples sent for QC from own laboratory
- Manage all defined stability programs in terms of protocl preparation, inventory management, analytical testing execution and data release
- Ensure all safety and quality events are investigated and root cause determined with CAPA’s identified and executed
- Coordinate the timely execution of the preventive maintenance program and execution of corrective maintenance.
- Keep up to date on new analysis techniques relevant to the laboratory, by means of literature, training, seminars or conferences
- Coordinate the TMs assigned to his/her area of responsibility, namely in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies, in order to ensure all TMs are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity
- Develop and propose for superior approval the activity plan and related budget for the Area under responsibility in line with the unit's strategy, in order to align activities with area strategic objectives
- Monitor Communication´s budget, by controlling budget evolution, identifying any deviations between the real and the foreseen and taking corrective measures
- Ensure compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) within his/ her TMs
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
- Masters’ degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences or in similar Chemistry/ Biochemistry/ Health Sciences fields
- Technical background preferred
- Typically requires 5 years of relevant experience in an Analytical Chemistry / Quality Control laboratory, preferably in a GMP environment
- Experience in leading others in project context
- Effective time management skills and the ability to multitask.
- Track record of overachieving targets
- Possess solid knowledge of Analytical Chemistry / Quality Control principles and practices
- Knowledge and experience of GMP and ICH guidelines
- Good communication skills (verbal and written)
- Skilled at managing processes and tools - Fluency in English is a requirement
- Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.

**Hovione is a proud Equal Opportunity Employer**

Inclusion and diversity are key to us. At Hovione, that means a work environment where differences are valued,

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