- Assist in generating and revising cGMP documents to encompass however now not restricted to SOP’s, Independent paperwork and Batch Records.
- Review and robotically audit documentation (SOP binders, personnel binders, certificates, etc.) verifying that data are modern-day.
- Coordinate relevant training with HR and training leadership.
- Manages the preservation and preventative protection log ensuring that calibrations/inspections are present day.
- Coordinates and maintains Smartsheet of accredited consumable with QA Pharmacist and Director of QA or Designee.
- Schedules habitual pest manipulate treatments for accepted seller and evaluations reports and trending statistics.
- Responsible for handling garage and disposal of production waste and retaining all records as evidence.
- Provides ordinary feedback to Director of QA regarding assigned projects and other activities.
- Knowledgeable and efficient in MS Word, Excel, Adobe/Nitro and SharePoint.
- Provides support in all regulatory inspections: FDA, DEA, Board of Pharmacy, and Internal Audits.
Knowledge Skills and Qualifications:
- Basic information of Document Control fundamentals, Quality Systems and GMP necessities.
- Understanding position of QA and QC in an employer.
- Ability to multitask and prepare time efficaciously.
- Excellent attention to element.
- Works efficiently with others as a part of a crew.
- 3 years of enjoy in Document Control (Preferably with Pharmaceuticals)
- Proficient expertise of Internal Auditing and Change Control practices in accordance with GMP requirements.
Salary: Not disclosed
Industry: Automobile / Auto Ancilliary
Functional Area: Others
Role Category: Others
Employment Type: Full time