Job Description
What you will do:
Bring energy, knowledge, innovation and leadership to carry out the following:
- Quality oversight of GMP compliance for engineering and validation deliverables related to projects including requirements definition, specification, engineering design, qualification and change management.
- Quality oversight of Shipping Qualification deliverables.
- Quality oversight of Maintenance & Calibration Program.
- Quality oversight of Pest Control Program.
- Quality oversight of Cleaning Validation Program.
- Evaluation and approval of deviations related to validation protocols in order to guarantee proper tracking/ documentation of the incidents and identification of corrective actions.
- Providing validation expertise and support for the development (or modification) of manufacturing facilities, equipment & systems.
- Providing support for Permanent Inspection Readiness Program, in preparation for agency inspections, as well as supporting Internal Audit Program as required.
- Collaboration and participation in projects as a Quality Representative for Validation.
- Providing support for Annual Product Quality Review and performing quality assessment for all engineering and manufacturing changes associated with validation activities.
- Ensuring the validation maintenance activities are executed as required including approval in a timely manner of the re-qualification / re-validation and periodic review activities.
- Participation in multi-site initiatives to ensure harmonization of validation activities across the network as required.
- Providing subject matter expert (SME) support for general troubleshooting, problem solving, technical direction and guidance to support overall business needs.
- Participation in the evaluation of Change Control and providing support in the review of the associated risk assessments.
- Supporting process deviation evaluation with regards to validation impact.
- Maintaining up-to-date knowledge of pharmaceutical legislation and industry best practice.
- Taking a collaborative approach, working cross-functionally on resolving obstacles to maintain a highly effective and productive team.
What skills you will need
- Bachelor’s Degree in sciences or Engineering (Chemistry, Biology, Pharmacy, Microbiology, etc).
- Minimum of 8 years’ experience in a QA/Validation related position within the pharmaceutical Industry.
- Strong experience with Validation in project related activities, including Controlled Area Facilities.
- Excellent communication skills (written and oral), including the ability to interaction with multiples stakeholders at all levels withing the business.
- Strong experience in Validation to ensure compliance to Annex 15, EU regulations and applicable US FDA Guidelines.
- Experience with Cleaning Validation & Verification.
- Demonstrated understanding of continuous quality / process improvement tools.
- Ability to multi-task and handle tasks with competing priorities effectively.
- Knowledge of/experience with aseptic processing and biologicals.
- Knowledge and understanding of EU and US cGMP regulations with respect to the validation, production and testing of pharmaceutical and/or biological products.
- Track record of utilising Risk Based Approaches to Qualification / Validation activities.
So, if you are ready to:
Current Contingent Workers apply
*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.