Quality Assurance Manager - Healthcare jobs in Somerset, NJ

JOB TITLE – QUALITY ASSURANCE MANAGER – AUDIT (6 MONTH CONTRACT)

The role of the Quality Assurance Manager (Audit) 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.

QUALIFICATIONS

• 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.

BAP Pharma is committed to enabling a supportive work environment, which is diverse and inclusive and based on mutual respect.

We offer comprehensive training and development programmes to employees to enable them to excel in their roles. We provide our team with a platform in which to continually progress and excel and deliver on our promises to our clients.

BAP Pharma – Promise delivered. Our people are results driven, tenacious and customer focused. If you think you have what it takes to be part of a successful team with an exciting future, please apply today!

Job Type: Full-time

Salary: From $90,000.00 per year

Benefits:

• Work from home

Schedule:

• Day shift
• Monday to Friday
• No weekends

Experience:

• Quality Assurance: 5 years (Required)
• External Audit: 1 year (Required)

Ability to Commute:

• Somerset, NJ 08873 (Preferred)

Work Location: In person