Quality Operations Technician
at PCI Pharma Services
Stamullin, County Meath, Ireland -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 26 Sep, 2024 | Not Specified | 27 Jun, 2024 | N/A | Good communication skills | No | No |
Required Visa Status:
Citizen | GC |
US Citizen | Student Visa |
H1B | CPT |
OPT | H4 Spouse of H1B |
GC Green Card |
Employment Type:
Full Time | Part Time |
Permanent | Independent - 1099 |
Contract – W2 | C2H Independent |
C2H W2 | Contract – Corp 2 Corp |
Contract to Hire – Corp 2 Corp |
Description:
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.
We are looking for a quality technicians to join our Team in Stamullen, Co Meath.
- Generate Packaging Instructions, Batch Packaging Records and labels for use in production from Master documents.
- Perform AQLs as required during production operations.
- 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 logbooks.
- Identify training needs in conjunction with the production manager and conduct staff training as required.
- Assist with environmental monitoring procedures, update spreadsheets to facilitate trending of results.
- 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.
- 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.
- 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.
- 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.
Let’s talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status
Responsibilities:
Please refer the Job description for details
REQUIREMENT SUMMARY
Min:N/AMax:5.0 year(s)
Hospital/Health Care
Production / Maintenance / Quality
Health Care
Trade Certificate
Request certificates of analysis / conformance for incoming goods packaging materials and product from customers/suppliers.
Proficient
1
Stamullin, County Meath, Ireland