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A contract manufacturing French pharmaceutical company at the forefront of innovation
Thanks to more than 25 years of experience and constant innovation, French pharmaceutical company Unither has established itself as not only a leading contract manufacturer in its home country, but also a pioneering pharma company at the international level. At our locations in France, the USA and Brazil, we provide comprehensive R&D, manufacturing and commercial facilities to meet every aspect of contract pharmaceutical manufacturing needs. We specialize in unit dose manufacturing and our expertise encompasses a wide range of unit dose packaging, such as liquid stick pack, powder stick pack and blow-fill-seal (BFS) technologies. In addition, we also manufacture effervescent and orodispersible tablets, suppositories and pessaries, and pharmaceutical bottles. Production lines and systems at both our French pharmaceutical company and USA pharma company sites are regularly inspected by the appropriate authorities to ensure our products’ compliance with relevant national and international standards.
This position is responsible for leading our validation team and managing our projects to meet the needs of customers, their projects, and commercial production. This position is responsible for ensuring that the validation activities are performed within an appropriate level of cGMP, HS&E and DEA compliance. Additionally, this position will have responsibility for overall project management of new and ongoing projects across functions. These responsibilities include, but are not limited to, planning, leading, resourcing all aspects of cross-functional projects from development through commercialization. Project activities are supported through matrixed resources, and the position ensures close and open communication within the site and with customer representatives. Ensures that the Validation group delivers on implementation of Continuous Process Verification, Serialization and Aggregation of current and future products.
- Lead team to develop and execute equipment qualification protocols for all manufacturing, processing, and packaging equipment as well as facilities supporting these operations.
- Track and report team activities to plan and milestone timelines.
- Ensure efficient communication of program status, potential problems and resolutions to issues.
- Analyze data, utilizing appropriate statistical methods, generated by validation studies performed by the group to determine process capabilities.
- Investigate and assist in resolving deviations/ exceptions from the predefined acceptance criteria.
- Draw conclusions from data, observations, deviation/exception and investigation as to whether a process is considered valid.
- Interact and coordinate with compliance efforts across departments including, but not limited to: Operations, Engineering, QA, QC, and development functions to provide a high degree of assurance that all qualification/validation activities are completed to requirements.
- Write summary reports (closeout report when applicable) for validation/qualification protocols following criteria as outlined within the validation/ qualification procedures and policies.
- Maintain protocols and system documentation in an orderly library so that information can be provided to regulatory bodies in a timely manner.
- Ensure that the Validation group delivers on implementation of Continuous Process Verification, Serialization and Aggregation of current and future products.
- Manage employee performance by clearly defining job responsibilities and standards of performance; tracking progress against goals; providing clear, thorough, timely feedback; and addressing performance problems and issues promptly.
- Stay abreast of changes in cGMP trends for validation and industry standards.
- A Bachelors degree in a technical or business discipline is highly preferred with 8 years experience in a role of similar scope/ complexity required.
- Background may be combined across engineering, quality assurance, and validation.
- Minimum 3 years process, product, equipment and/ or cleaning validation is preferred.
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