What are the responsibilities and job description for the Audit and Regulatory Manager position at LSNE/PCI Pharma Services?
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.
General Purpose of Role:
- To provide support to Director of Quality and Regulatory Services Group (PCI-QRS) and deputise in their absence.
- To conduct audits of manufacturing and testing facilities in accordance with EU/UK GMP requirements
- To provide support with customers regulatory requirements (IMPD/IND writing) on an ad hoc basis
Main Responsibilities:
- Conduct audits in line with the required schedule (audit standard is EU/UK GMP guidelines), ensuring:
- Proper engagement with the customer to understand scope of the audit and any issues that may be ongoing with the site to be audited
- Audit agenda is prepared and sent to the audit site at least 4 weeks prior to the audit date (when possible)
- Audit is conducted in line with the timeframe stipulated on the agenda
- Audit reports are written in a timely fashion post audit completion, at the latest no later than 30 days from the date of completing the audit.
- Audit responses are followed up with the audit site (should be provided no later than 30 days after the report is sent)
- Audit responses are reviewed for acceptability
- Audit closeout is documented within PCI QMS.
- Provide support for additional regulatory services when a requirement is identified
- IMPD/IND writing
- Provide a trouble shooting QMS service to customers on an as needed basis
- Deputise for the Director of Quality and Regulatory Services on occasion when they are unavailable for both external and internal meetings.
Outcomes of Role:
- Delivery of the QRS audit programme
- Providing a premium audit service
- Customer satisfaction with service (internal and external).
Specific Qualifications:
- Extensive Quality and/or regulatory experience within the medicinal products/ pharmaceutical industry.
- A minimum of a first degree in a related disciplines (Life Science, Pharmacy, Regulatory Affairs etc)
- Additional qualification as an auditor or lead auditor is beneficial
- Experience in wide range of dosage forms: solids oral dosage forms, liquids, creams, suspensions, sterile, biological and ATMP
- Experienced and knowledgeable of the requirements of EU/UK (and FDA) GMP regulations and directives and with a desire to stay current as regulations change.
- Experience in clinical and commercial manufacturing
- Experience with the requirements of the Common technical dossier
- Good IT skills (at least MS Word).
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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.
LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company’s EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.