This role is Onsite only.
Qualifications:
General Competencies:
* Leadership skills coupled with good oral and written communication skills.
* Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work/ upskill/coach a team environment.
* Demonstrated analytical aptitude, critical thinking skills and problem-solving skills.
Technical:
* Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.
Minimum Education/Experience:
* Bachelor's degree, in a scientific or engineering field.
* 3 years of relevant post-degree experience in a GMP environment: manufacturing,
laboratory, quality, operations, technical, or regulatory function.
Responsibilities:
* Provide direct Quality support to production and support areas.
* Provides presence on the shop floor to support compliance and data integrity.
* Review and approve GMP documentation/data for accuracy and completeness.
* Review and approve executed production documentation such as electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures and ensures completion of proper remediation of errors.
* QA support, review and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment.
* QA support, review, and approval for Performance qualification (PQ) & Process Validation activities across site.
* Support sustaining and QC activities such as change management, deviations, CAPAs, equipment requalification, periodic review, site maintenance and Calibration Programs.
* Provides support to internal audits and regulatory inspections.
* Collaborates with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans
