What an audit-ready file contains
Auditors usually ask three things about a named person: what qualifies them, what their job description says, and what they were trained on. Keep a signed, current job description for every GMP role, updated when responsibilities change, next to the certificates that justify the role.
- Degree certificates and marksheets
- Experience letters showing earlier pharma roles
- Signed current job description
- Medical fitness report where your procedure calls for one
- Training certificates with dates
- Identity, address, bank and nominee papers
Approvals and key person records
Heads of production and quality control are often named as technical staff on the manufacturing licence, and their approval papers belong in their file. When they change roles or resign, regulatory affairs has work to do. Keep these approvals with a review date where one applies, and keep a short list of licence-named employees so HR knows whose resignation needs regulatory planning from day one.
Medical fitness and periodic checks
Many plants ask for medical fitness for production staff at joining and at intervals after that, and some tasks need a specific test, such as eyesight for visual inspection. Store each report with its date and the next due date. Reports hold personal health details, so limit who can open them. A production supervisor needs to know that a person is fit for the area, not what the report says.
Documents for the field force
For MRs, the file holds identity and bank papers, the headquarters and territory assignment, a driving licence where the MR rides a two-wheeler for work, and signed acknowledgements for samples, detailing aids and devices issued. Update the territory record whenever an MR moves headquarters, because allowances, the holiday list and state professional tax all depend on it.
How to set it up in ZeniaHR
- Set the required-document checklist per role, including a signed job description and medical fitness for plant roles.
- Check each upload in Employee Documents, marking it verified or rejected, and set expiry dates for fitness reports, licences and approvals.
- Keep job description formats and acknowledgement letters in the HR letter library, filed by category.
- In Access Control, give the ready Auditor role a data scope limited to the plant branch, and mask salary and bank fields.
- During audits, share files through secure time-limited download links instead of email attachments.
- Run the document reports monthly to find missing job descriptions and fitness reports falling due.
Read more about employee documents in ZeniaHR.
Roles this applies to
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What employee documents do pharma auditors check?
Auditors commonly check qualification certificates, a signed and current job description, and training records for people doing GMP work, and sometimes medical fitness for production staff. They often start from a batch record and ask for the files of the people named on it. Keep these documents verified, current and quick to retrieve.
Why do pharma companies keep signed job descriptions?
A signed job description shows that each person knows their responsibilities and that the tasks they perform match the role. Auditors compare it with training records and the documents the person signs. Update it when responsibilities change, have the employee and manager sign the new version, and keep the old one on file.
Who should see an employee's medical fitness report?
As a rule, only HR and the medical officer. Supervisors need to know that a person is fit for the area, not the details of the report. Store reports in the employee's documents with access limited by role, and share only the fitness status with the production team.