Address
Form of work- Responsible for first level, hands on, day-to-day cGMP facilitator role for all site related GMP activities.
- Interact directly with site staff, who are performing the daily operational functions in support of their effort to produce quality products.
- Ensures that the quality strategy is implemented and that there is a continuous drive to improve product and process quality within the PU.
- This position will be expected to work a 4 day/10 hours work shift. (Sunday through Wednesday or Wednesday through Saturday, some evenings may be required).
- Under the guidance of the Quality Operations Process Manager/Team Manager, provides oversight to operations on the shop floor, supporting operators and support staff as needed to identify and address product quality and compliance issues as they arise.
- Review and audit production batch records to ensure adherence to policies, SOPs, and cGMP requirements.
- Conduct routine shop floor tasks related to aseptic operations including but not limited to ViMOS, APV program observations, walkthrough program, QA area release, etc.
- Interface closely with PU to assist with batch record review, release and compliance issues.
- Under the guidance of the Quality Operations Process Manager/team manager, perform triaging of events, initiate deviation reports in the appropriate quality system and partner PU and other areas for issue resolution.
- Actively participate in process improvement initiatives aiming for Right First Time (RFT) on documentation and deviation reduction.
- Ensures adequate levels of documentation are adequate and compliant to existing procedures.
- Review and approval of track and trend and minor deviation investigations and assist in CAPA plan establishment in accordance with applicable SOPs.
- Participates in activities associated with event resolution and CAPAs with a focus on organizing and attending cross-functional meetings.
- Implements and ensures adherence of appropriate regulations and quality standards.
- Write, review and approve Standard Operating Procedures (SOPs), as needed.
- Assist QA Experts, Process Manager, and Team Management in providing documentation as needed for self-inspections and external audits.
- Assist in audit preparation for shop floor tours as needed.
- Champion a Quality Culture and ensure a safe working environment.
- Complete job-related training as required.
- Perform or support any other tasks necessary to maintain the product quality and site cGMP compliance, as needed.
- Demonstrates and role models the values and behaviors.
Requirements
- BA degree in Biological Sciences or equivalent relevant career experience may be accepted.
- A minimum of 2 years of experience in a Pharmaceuticals environment.
- Knowledge and understanding of cGMPs, keeping up to date with current industry issues and changing regulations.
- Excellent oral and written communication skills required.
- Demonstrate leadership ability and excellent interpersonal skills.
- Ability to work under direction of senior team members, independently, and as part of a team if necessary. Strives for simplicity and clarity.
Preferred:
- SAP, Trackwise, MES, LIMS knowledge preferred.
- Experience in Deviation Management and batch disposition preferred.
As an equal opportunity employer, ICONMA prides itself on creating an employment environment that supports and encourages the abilities of all persons regardless of race, color, gender, age, sexual orientation, citizenship, or disability.
