Pharmaceutical Technology Specialist
The successful candidate will be part of the Validation Department responsible for the qualification/validation of all CGMP equipment, systems and processes.
Key Responsibilities:
* Oversee, coordinate, guide and implement the site validation master plan under prospective, concurrent and retrospective validation studies in a timely manner with relevant engineers.
* Evaluate new processes, equipment or changes to existing processes/equipment to ensure compliance with regulatory requirements.
* Actively work on validation projects as departmental point person, completing associated project documentation in line with corporate and regulatory expectations.
* Compile, authorise and file validation study documentation in a timely and organised fashion.
* Work with other validation engineers to achieve compliance by co-ordinating each validation project assigned.
* Facilitate PQR review process/Laboratory Equipment Review Process as per current rota.
* Stay ahead of current and changing regulatory guidance for relevant areas of validation.
* Provide support for audit preparation, direct audit interaction and involvement in audit response.
* Support and comply with internal EHS requirements, procedures and policies ensuring continued conformance to EHS within the department.
* Achieve quality objectives through continuous improvement efforts and conformance to quality standards.
Requirements:
* Rlevant 3rd Level Qualification is essential.
* Experience in Pharmaceuticals Manufacturing/Production is essential.
* Demonstrate exceptional project management skills, proficient in Microsoft Office suite of programs.
* Experience with Validations processes is essential. Excellent communication, organisation, time-management and teamwork skills.
* Demonstrate ability to work on one's own initiative with a passion for results.
* Ability to articulate clearly when dealing with colleagues, peer groups and managers.
* Ability to plan and schedule workload.
* Ability to work well under pressure consistently delivering results while demonstrating an action-oriented approach to overcome obstacles.