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IRE_Quality Operations Technician
5 months ago
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Primary Responsibilities:
1) Generate Packaging Instructions, Batch Packaging Records and labels for use in production from Master documents.
2) Perform AQLs as required during production operations.
3) Sampling, approval and release incoming goods, packaging materials and product (where required) for use in production.
4) Request Certificates of Analysis / Conformance for incoming goods, packaging materials and product from customers/suppliers. Review and filing of same.
5) Review and filing of stock cards, approval forms, equipment LUMAC logs and other production log books.
6) Identify training needs in conjunction with the production manager and conduct staff training as required.
7) Assist with environmental monitoring procedures, update spreadsheets to facilitate trending of results.
8) Ad-hoc checks, in-process checks and documentation review on a routine basis on production lines.
9) Approval of Line clearance procedures.
10) Approval of Pre-production samples.
11) Maintenance of batch documents and retain samples in archive. Update the PQR database after QP release.
12) To liaise with Customers / suppliers for artwork related queries and management of approval of artwork.
13) Raise Deviations, Corrective Action Requests, Non-Conformance reports as required and in a timely manner and ensure that issues are communicated to the QC Manager/designee.
14) Ensure activities observed are in compliance with the requirements of cGMP.
15) Assist in performing validation studies.
16) Ensure safe work practices are being followed at all times, report any defects immediately to the Safety Officer and attend Health & Safety meetings.
17) Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
Join us and be part of building the bridge between life changing therapies and patients.
