Job Overview
We are seeking a skilled Manufacturing Specialist to join our team. This role involves daily production operations and requires documentation of activities according to cGMP requirements.
Main Responsibilities:
* Final Product Inspection: Conduct thorough visual inspections of final products.
* Documentation Management: Maintain accurate records of activities in line with cGMP requirements.
* Material Verification: Verify receipt of materials from the warehouse.
* Manufacturing Documentation: Ensure timely completion of manufacturing documentation without errors, adhering to cGMP standards.
* Quality Record Keeping: Maintain detailed records of operations carried out during each work shift.
* Active Participation: Participate in Factory Acceptance testing, Site Acceptance Testing, and commissioning/qualification of equipment.
* Policy Adherence: Comply with all relevant policies related to Quality & Safety.
* External Inspections: Facilitate successful external inspections and Division/Corporate audits.
* Batch Record Development: Contribute to the development of batch records and electronic batch records for the site.
Requirements
To be successful in this role, you will require:
* Certificate and Experience: A minimum of 1 year's experience in GMP manufacturing or equivalent.
* GMP Knowledge: Strong knowledge of GMP and regulatory requirements related to the pharma/biologics industry.
* Batch Processing: Prior experience in batch processing operations within an FDA/HPRA regulated industry is highly desirable.
* Vision Certification: Annual visual test certification for color blindness and 20/20 vision is mandatory.
* cGMP Knowledge: Good understanding of cGMP and regulatory requirements related to the biologics/pharmaceutical industry is desirable.
* Dangerous Chemicals: Experience handling dangerous chemicals is highly desirable.
* I.T. Skills: Excellent I.T. skills are required.
* Inspection Experience: Previous inspection experience in a Pharma/Biologics facility is a significant advantage.