QC Auditor

Gerresheimer is an innovative systems and solutions provider and a global partner for the pharma, biotech and cosmetic industries. The company offers a comprehensive portfolio of pharmaceutical containment solutions, drug delivery systems and medical devices as well as solutions for the health industry. The product range includes digital solutions for therapy support, medication pumps, syringes, pens, auto-injectors and inhalers as well as vials, ampoules, tablet containers, infusion, dropper and syrup bottles and more. Gerresheimer ensures the safe delivery and reliable administration of drugs to the patient. With 35 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for regional markets. With around 12,000 employees, the company generated revenues of around €2bn in 2023. Gerresheimer AG is listed in the MDAX on the Frankfurt Stock Exchange (ISIN: DE000A0LD6E6).

Job Summary

The Pharmaceutical Packaging Auditor is responsible for monitoring the manufacturing process of vial and glass cartridge products to ensure compliance with product specifications and quality standards. This role involves conducting audits, reviewing data, and providing timely feedback to the manufacturing team regarding process performance and product quality. The auditor will also play an integral part in ensuring the final products meet all quality requirements before they are shipped to customers.

NOTE: This opening is for a NIGHT SHIFT 12-HOUR ROLE 7pm-7am (3 on 2 off, 2 on 3 off)

Essential Functions

• Quality Assurance & Monitoring:
• Ensure finished products conform to specifications before being released for shipment.
• Review available quality data, including statistical process control reports, and perform final acceptance product audits.
• Conduct routine random sample inspections from each machine chuck, evaluating them according to product requirements.
• Approve the first piece inspections and oversee product line changes.
• Audits & Inspections:
• Perform routine dimensional and visual audits of products to ensure compliance with specifications.
• Document all audit results in accordance with Standard Operating Procedures (SOPs).
• Collaboration & Reporting:
• Report process deviations or product issues to packers, operators, and supervisors in a timely manner.
• Communicate unusual product or customer requirements to manufacturing teams.
• Participate in investigations regarding process or product issues.
• Documentation & Compliance:
• Complete all process and product documentation accurately and legibly.
• Demonstrate a strong understanding of AQL (Acceptable Quality Level) and GMP (Good Manufacturing Practices) standards.
• Interpret customer specifications, part drawings, and tolerancing methods to ensure product compliance.
• Other Responsibilities:
• Perform additional duties as required or requested by management.

Qualifications:

• Familiarity with GMP and AQL standards in the pharmaceutical industry.
• Ability to understand and interpret product specifications, customer requirements, and part drawings.
• Strong attention to detail, organizational skills, and the ability to communicate effectively.
• Experience in quality assurance, auditing, or a related field is preferred.