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Primary Job Responsibilities:
- Generate Packaging Instructions, Batch Packaging Records and labels for use in production from Master documents
- Perform initial review of completed batch documentation to present to the Qualified Person for batch release. Send batch documentation and samples to customers after QP release.
- Sampling, approval and release incoming goods, packaging materials and product (where required) for use in production.
- Request Certificates of Analysis / Conformance for incoming goods, packaging materials and product from customers/suppliers. Review and filing of same.
- Review and filing of stock cards, approval forms, equipment LUMAC logs and other production log books.
- Identify training needs in conjunction with the production manager and conduct staff training as required.
- Assist with environmental and microbiological monitoring procedures, update spread sheets to facilitate trending of results.
- Ensure that all SOPs and their indexes are maintained and reviewed on time. Distribution of authorised SOP's, Forms and BPR's. Retrieval of obsolete / superseded SOP's, BPR's and Forms. Assist with review of SOP's, BPR's and Forms.
- Ad-hoc checks, in-process checks and documentation review on a routine basis on production lines.
- Approval of Line clearance procedures.
- Approval of Pre-production samples.
- Maintenance of batch documents and retain samples in archive. Update the PQR database after QP release.
- To liaise with Customers / suppliers for artwork related queries and management of approval of artwork.
- Prepare Master Packaging Material Specifications and Packaging Instructions.
- Ensure excellence in Housekeeping. Carry out Housekeeping audits and prepare the reports.
- Raise Deviations, Corrective Action Requests, Non-Conformance reports as required and in a timely manner.
- Ensure activities observed are in compliance with the requirements of cGMP.
- Assist in performing validation studies.
- Ensure safe work practices are being followed at all times, report any defects immediately to the Safety Officer and attend Health & Safety meetings.
- Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
Please post your Curriculum Vitae to Millmount Healthcare Limited, Block 7, CityNorth Business Campus, Stamullen, County Meath or email to firstname.lastname@example.org