Hovione is an international company with over 55 years’ experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With four FDA inspected sites in Portugal, the U.S., Ireland and China, Hovione offers integrated API, particle design, formulation development and GMP manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services.
To reinforce our team we are looking to fill the following position at our Loures site:
LIMS Technical Expert (M/F)
The LIMS Technical Expert will be responsible to assure that tests and specifications introduced in LIMS, CDOC and other internal systems, are validated and in accordance with the internal requirements and will guarantee the validated status of LIMS and CDOC systems. This Technical Expert will also be responsible to manage compendia methods to keep them updated to the most recent Pharmacopeia revision at all sites in order to ensure compliance with the guidelines.
- Cooperate in the development, testing and implementation of software applications that support laboratory work related namely with LIMS and CDOC;
- Ensure that the requests to introduce changes in the computer systems are duly controlled, tested and validated;
- Participate in the validation of changes introduced in LIMS and CDOC systems, from the user’s point of view;
- Provide training in LIMS, CDOC and other internal (Analytical Methods) applications, whenever required;
- Prepare the technical or training documentation to be used in the training sessions;
- Prepare and update material specifications in the LIMS/CDOC systems (stability, raw material, intermediate and finished product);
- Prepare, review, approve and make effective analytical methods;
- Participate with IT in the process of allowing access to all LIMS users;
- Audit LIMS system to ensure all the users are feeding the information required in audit trail;
- Oversee users accesses to ensure it is updated with the actual staff at all times at all sites;
- Prepare and review applicable procedures (IOP, SOP and COP);
- Promote the uniformity of documents at all sites;
- To assure and promote compliance on Health, Safety and Environment in the area and activities for which is responsible or in which participates.
- Degree in Pharmaceutical or Chemistry areas, or equivalent degree in a scientific area;
- Experience of a minimum of 3 years in an analytical operational area(s) in the Pharmaceutical or Chemical Industry;
- Good understanding and proficient application of Quality requirements, cGMP´s, ICH/CFR guidelines, ISO Standards and Industrial Safety;
- Business understanding;
- Analytical skills;
- Good arithmetical reasoning ;
- Good knowledge in computer applications, as user;
- Critical and proactive personality;
- Accuracy and responsibility;
- Responsibility and initiative;
- Independence and organization;
- Full time opportunity;
- Remuneration and social benefits adjusted to the job function and matching the experience;
- Excellent work environment, with a strong focus on quality.