Quality Assurance Auditor
3 weeks ago
Position: QA Auditor (6 MONTH CONTRACT)
This is a remote role, onsite 1-2 times per month(costs will be covered)
The role of the Quality Assurance Auditor is to support the Senior Manager in ensuring that that BAP US Inc. is compliant with cGMP, GDP, FDA, EU and ICH regulatory requirements concerning
comparator sourcing, secondary packaging & labelling, release, storage and distribution of medicinal products. The role will be responsible for supporting BAP in conducting its external
audits, particularly with suppliers and regulatory bodies.
- Responsibilities: Responsible for supplier and customer qualification prior to sourcing or supplying. Perform on-site audit of suppliers as part of the supplier qualification process where necessary.
- The postholder must have solid experience in hosting/performing external audits.
- Liaise with suppliers and co-ordinate audit schedules.
- Generate audit agenda, maintain schedule with updates as required.
- Perform supplier audits to ensure compliance with regulatory and industry standards.
- Generate audit reports.
- Manage post-audit activities and follow-ups on any necessary CAPA.
- Conduct Self Inspections.
- Requirements:Auditing Certification (i.e., ASQ)
- Minimum five years' experience as a quality auditor in the pharmaceutical industry.
- In-depth knowledge of cGMPs / GDPs regulatory/ industry standards (21CFR part 11, 21CFR
- part 211, 21CFR part 210, ISO 9001).
- Excellent communication, organization, and attention to detail skills.
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