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.
Summary of Role Sampling, approval and release incoming good, packaging materials and product (where required) for use in production.
Request Certificates of Analysis / Conformance for incoming goods, packaging materials and product for use in production.
Review and Filing of acetates for use in sampling.
Identify training needs and conduct staff training as required.
Maintenance of sampling documentation and retain samples in archive.
Management of the Supplier/Customer Defect (SCD) system.
Issue the SCD numbers, coordination of completion of the SCDs with the customer/supplier and close out of the SCD.
To liaise with customers/supplier for artwork related queries and management of approval of artwork.
Review and approval of Master Packaging Material Specifications.
Ensure excellence in Housekeeping.
Carry out housekeeping audits and prepare the reports.
Raise and close deviations and Corrective/Preventative actions as required.
Ensure activities observed are in compliance with the requirements of cGMP.
Assist in validation studies as required.
Ensure safe work practices are being followed at all times, report any defects immediately to the Safety Officer and attend Health and 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.
Secondary Responsibilities Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
Knowledge / Skills