Back to search.Morgan McKinley - Quality Operations Manager
| Employment Type: | Permanent |
| Location: | Dublin Region, Ireland |
| Salary: | €1 - €2 per annum + negotiable |
| Languages: | English |
My client is a CMO-based pharmaceutical group seeking to hire a Third Party Manufacturing Quality Operations Manager to oversee the management of relationships with external suppliers and manufacturing sites.
The key responsibilities of the position will include:
* Manage the relationships between the client and TPM organisations with respect to quality
* Maintaining quality oversight of solid dose and sterile manufacturing operations
* Support EMEA-wide quality operations where required on behalf of the client
* Engage with the Manufacturing and Technical Services Departments where required on all matters pertaining to product quality
* Development of quality department processes for Annual PQRs, RFTs, and review/approval of quality agreements
* Be the group quality representative for all technical transfer projects
* Act as back up to the QP on quality matters and batch approval where necessary
The successful applicant, aside from having extensive experience in a senior quality capacity within the pharmaceutical industry, will have the following experience and expertise:
* In depth knowledge of the solid dose manufacturing process, coupled with extensive exposure to sterile manufacturing.
* Strong quality systems management experience.
* Extensive experience with CMO-based quality systems
* Management of complex technical agreements with suppliers and TPMs
* Knowledge of all facets of quality, including validation, manufacturing review, packaging and supply chain
This is a very exciting position, and a rare opportunity to join a well established and highly successful quality team with a leading global pharmaceutical group. In addition to a market-leading salary and remuneration package, this position will offer applicants the opportunity to gain and improve their experience with contract manufacturing organisations, work on and manage cross-functional projects, as well as offering the opportunity to move towards regional and global QA management. Applications are invited from suitably qualified candidates for this position.
The key responsibilities of the position will include:
* Manage the relationships between the client and TPM organisations with respect to quality
* Maintaining quality oversight of solid dose and sterile manufacturing operations
* Support EMEA-wide quality operations where required on behalf of the client
* Engage with the Manufacturing and Technical Services Departments where required on all matters pertaining to product quality
* Development of quality department processes for Annual PQRs, RFTs, and review/approval of quality agreements
* Be the group quality representative for all technical transfer projects
* Act as back up to the QP on quality matters and batch approval where necessary
The successful applicant, aside from having extensive experience in a senior quality capacity within the pharmaceutical industry, will have the following experience and expertise:
* In depth knowledge of the solid dose manufacturing process, coupled with extensive exposure to sterile manufacturing.
* Strong quality systems management experience.
* Extensive experience with CMO-based quality systems
* Management of complex technical agreements with suppliers and TPMs
* Knowledge of all facets of quality, including validation, manufacturing review, packaging and supply chain
This is a very exciting position, and a rare opportunity to join a well established and highly successful quality team with a leading global pharmaceutical group. In addition to a market-leading salary and remuneration package, this position will offer applicants the opportunity to gain and improve their experience with contract manufacturing organisations, work on and manage cross-functional projects, as well as offering the opportunity to move towards regional and global QA management. Applications are invited from suitably qualified candidates for this position.
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