PCI TRGR Penn Pharmaceutical Services Ltd
Location
Northern Ireland | United Kingdom
Job description
Audit and Supplier Qualification Specialist page is loaded
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.
Main purpose of job:
The role is to implement and execute tasks relating to GMP auditing and supplier qualification in the PCI sites in Ireland.
Main responsibilities:
Ensure on-going compliance with customer, regulatory and internal requirements. Management and co-ordinate all aspects on site Supplier Management Programme, including supplier audits, preparation of QTA’s and supplier qualification. Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required in a timely manner and ensure that issues are communicated to the auditing Manager/designee Ensure activities observed are in compliance with the requirements of cGMP Generation of SOP/Forms/JA's/WI's on MasterControl Support, participate and host both Client and Regulatory audits. Ensure safe work practices are being followed at all times, report any defects immediately to the Safety Officer and attend Health & Safety meetings. Interact and communicate daily with staff and support departments. To undertake such tasks and to manage specific and/or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities.
Requirements
To have demonstrable experience within Quality Systems.
Good working knowledge of cGMP.
Good interpersonal skills.
Good Written communication skills
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.
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