Quality Assurance Auditor Sagent Pharmaceuticals
Senior Manager Facility Compliance
Basic Function: To conduct audits/inspections of new and existing suppliers and vendors in support of the new and commercialized products. Responsible for scheduling, performing, and reporting the supplier/contractors inspection results.
- Bachelor Degree in engineering or sciences (i.e.: chemistry, microbiology)
- At least 5 years of progressive challenging QA/QC experience in the pharmaceutical industry with at least 2 years of pharmaceutical or similar auditing experience
- In-depth knowledge of cGMP, cGLP, Aseptic Processing, as well as FDA regulations, guidelines, and trends
- Capable of working independently and part of a team, able to coordinate multiple projects.
- Must possess exceptional communication and organizational skills.
- Ability to travel domestic and internationally 40% to 50% of the time based on the schedule.
1. Schedules audits as assigned per the audit schedule and conducts initial, routine, and for-cause cGMP internal and supplier audits. External audits are related to Sagent?s suppliers including contract manufacturers of parenteral finished drug products, sterile and non-sterile active pharmaceutical ingredients, formulation development and analytical contract laboratories, clinical sites, etc.
2. Assists in monitoring, scheduling, conducting, and reporting of cGMP activities for Sagent?s suppliers and partners.
3. Provides audit reports at the conclusion of the audit to the applicable site and Sagent personnel, and concludes the supplier?s compliance status based on the internal and regulatory requirements.
4. Files audit and correspondence records related to the audits performed in accordance to Sagent?s procedures.
5. Reviews and assesses the audit responses against the current industry standards and guidelines, and follows- up on the implementation of the corrective actions associated with the audit observations until closure of the audit.
6. Provides quality evaluations of suppliers and contractors in accordance to Sagent?s procedures and as directed by the management.
Specific Technical/Job-Related Skills:
- In depth knowledge of current GMP and GLP as well as FDA trends and guidelines.
- Expertise in FDA cGMPs with a focus on aseptic liquid and powder filling, lyophilization, and terminal sterilization processes.
- Possesses strong organizational skills for prioritizing workload and responsibilities.
- Strong written communication, interpersonal, negotiations and problem solving skills are required.
- Proficient with PC-based word processors, databases and spreadsheets.
||1901 North Roselle Road |
Schaumburg, IL 60195