Responsibilities:
- Provide QA oversight to operational activities taking place within the aligned cell.
- Review of sterilization cycles, FMS systems and other key controls of clean rooms.
- Review of logbooks & support area controls.
- Online review of batch records.
- Closure of batch records with associates LIMS & SAP transactions & C of A generation.
- Review and update of Standard Operating Procedures and Controlled Documents as required.
- Supervision of clean rooms and support areas; comportment & compliance to SOPs – including actual entry into the clean rooms and maintenance of a minimum of a L1 license.
- Supervision of packaging areas; comportment & compliance to SOPs.
- Proactive generation and timely investigation/review of minor DRs & CAPA in conjunction with other cell members
- Proactive generation and timely review/implementation of level 0 & level 1 change controls in conjunction with other cell members.
- Local area & local system audits.
- Training/coaching of Operations staff & QA peers.
- Communicate effectively with other employees and participate with them in planning and problem solving activities, as required.
- Provide effective re-validation resources to the aligned cell.
- Media fill observation, incubation, reading & report writing.
- Clean room full physical – velocities, air patterns, DOP tests & particle counting.
- Autoclave load pattern re-qualification.
- De-pyrogenation tunnel requalification.
- Sterilizing filter testing.
- Cleaning Validation.
- Support clean room openings and month end client service targets by the provision of appropriate cover – e.g. weekends.
EH&S:
- Understand emergency procedures and comply with safe systems of work.
- Ensure compliance with environment, health and safety and security policies and procedures, rules, signage and instructions at all times
- Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules
Minimum Requirements/Qualifications:
- Substantial experience working within a pharmaceutical quality function, preferably “steriles”.
- Significant experience working within equipment/facility validation preferably “steriles”.
- Working knowledge of the principles and guidelines for GMP as set out in the ‘Orange Guide.’
- Relevant science based degree; e.g. Chemistry, Biology, Pharmacy preferred.
- Excellent interpersonal skills with the ability to appropriately challenge others behaviours.
- Excellent report writing skills.
- Good time management.
- Proactive approach to project work with a willingness to do what needs to be done to deliver the project milestones.
- Pragmatic / common sense approach to quality incidents.
- Proven experience to problem solving – essential.
- Demonstrable ability to make sound risk based decisions.
- Ability to perform internal audits.
- Front line QA for regulatory audits related to the Condo and Commercial areas.