For our client a global pharmaceutical company in Switzerland, we are looking for a contractor to fill the position of Senior Specialist, QA operations.
The QA Operations team is committed to actively supporting the company’s Manufacturing site and other departments to ensure cGMP compliant production, testing, and release of products on the manufacturing site. This position is responsible for quality assurance (QA) involved primarily with the support of the different quality system tools in place to ensure cGMP compliance throughout the manufacturing site.
The position holder will be responsible for the assigned processes and activities within QA Operations and will act as a member of the team supporting site operations. The scope included within this position is broad and includes bulk manufacturing, semi-finished and finished goods production, warehousing, and support functions such as metrology, maintenance, and projects.
The activities include responsibility for the execution of the main following processes: deviation and CAPA, change control handling, QA oversight of validation and qualification activities and support for new product/equipment introduction. Additional tasks are batch record review, risk assessments, as well as the support of health authorities’ inspections and corporate audits.
The Senior Specialist, QA Operations can be assigned special tasks in cross-functional projects to support the manufacturing site activities like new product introduction and launches.
This position will be working closely with the QA Operations management to identify and handle process quality and cGMP compliance-related issues, ensure the lean release of batches, and raw materials for production, as well as to contribute to process improvement in his/her scope of activity.
This position will also support quality on the floor for manufacturing, packaging, and warehousing activities in collaboration with the other members of the quality operation team. The team works closely with the QA operation release team to achieve the site objectives and release the products on time. As part of the quality on the floor organisation, the ability to solve issues on-call is required.
The Senior Specialist QA is also a key member of the site governance through the tier meetings
processes. They are responsible for addressing quality topics, taking appropriate decisions at the right level, and bringing any escalation to management, if necessary, in a clear and factual manner. This position is key to facilitating problem resolution at the right level.
The Senior Specialist, QA Operation can work autonomously, carry escalation, and follow all the topics from start to end in a proactive manner and behaviour.
At least 5 years of experience in a pharmaceutical company or other related industry.
BS or MSc in Science or related field.
Good understanding of cGMPs and FDA regulatory requirements.
Good understanding of solid oral dosage form manufacturing processes is preferred.
Proven interpersonal, collaborative and organizational skills. Ability to handle several tasks simultaneously.
Thorough understanding of cGMP requirements
Works independently on routine tasks, makes proposals and facilitates decisions when escalation is needed.
Ability to focus attention to details and analytical thinking
Good written & oral communication skills.
Excellent Investigational and problem-solving skills.
Good Knowledge of most common office software (Microsoft Office).
Fluent in French and English
Duties and Responsibilities
Supports the deviation process. Ensure (and lead if necessary) that the initial quality assessment is completed in a timely manner according to requirements, support investigators and assess criticality, review and approve the deviations and related CAPA.
Support the CAPA process by approving all the CAPA plan, and the completed action. Ensure review and approval of effectiveness check.
Supports the change control process. Performs action plan evaluation and coordinates change control progress within assigned areas of responsibility.
Reviews and approves as QA representative qualification and validation activities documents (protocols, reports…).
Perform batch record review and prepare batch release documentation on support of the Quality release team.
Contributes to risk assessments, e.g. related to quality issues or projects like new product introduction.
Represents QA within department and cross-functional project teams according to assignments.
Acts as backup for colleagues within QA Operations team.
Contributes to SOP/WP revision. Can take ownership of processes and document revision.
Supports health authorities and internal inspections in different roles (SME, coordinator, etc.
Participate to Quality KPI establishment and monitoring
***This position has now been filled, please contact firstname.lastname@example.org to be informed of future similar positions***