GullyHR
Pharmaceuticals and Life Sciences

Employee Administration for Pharmaceuticals and Life Sciences

Records, attendance, leave and the day-to-day HR that must simply work.

What this looks like in pharmaceuticals and life sciences

The parts of employee administration that are specific to this sector, rather than general.

Records That Are Part of the Quality System

Where the employee file has two owners.

What this covers

In a regulated manufacturer some employee records are HR documents and some are quality records, and the distinction determines who owns them, how they change, and how long they are kept.

HR records

  • Contract, terms and variation documents
  • Leave, attendance and payroll records
  • Performance and disciplinary records
  • Personal and contact information

Quality records

  • Training and qualification records
  • Signature and initials register
  • Area and clean-room authorisations
  • Job description as a controlled document
  • Ownership defined for each record category
  • Controlled change and audit trail where required
  • Retention periods applied per the correct basis
  • Retrieval for inspection without manual assembly
  • Access control appropriate to record sensitivity
  • Records retained after exit per the applicable requirement

The general method — what employee administration covers, the questions it answers and what an engagement produces — is the same whatever the sector, and is set out on the employee information management page. What is above is the part that differs for pharmaceuticals and life sciences.

Where to start

Most engagements begin with a review of how this runs in your business today, then a written process and the sequence to implement it.

See all HR topics for pharmaceuticals and life sciences, or another industry.

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