**Summary**:
This Role provides oversight of all GMP documents ( SOPs, FRMS, WPS) and ensures that all documents are updated, trained and effective in alignment with the department needs
**About the Role**:
**Major accountabilities**:
- Revise existing or create new SOPs in time to support Manufacturing Strategy.
- Ensure periodic review is completed on time
- Coordinate updates with cross functional teams for CAPAs, QEs, Health Authority inspections
- Ensure proper training compliance of all associates in
- Develop appropriate Individual training plans in collaboration with team leads
- Stay current regarding industry standards and ensure that all SOPs are cutting edge and incorporate all latest regulatory and quality requirements
- Support Quality Manual implementation through support of gap assessments and implementation of relevant content into SOPs and daily operation.
**Key performance indicators**:
- MBR right first timeReduction of batch record cycle timeReduction of operational errors98% training compliance of all associatesNo critical audit findings pertinent to SOPs/MBRs
**Work Experience**:
- 3-5 or more years of related experience in cGMP/FDA regulated industry.




- Pharmaceutical GMP's - strong knowledge of Good Manufacturing Practices and regulatory knowledge is a requirement.
- Knowledgeable in ESOPs; LMS (Learning Management Systems),
- TrackWise; MES knowledge is a plus
**Skills**:
- Assembly Language.
- Cooperation.
- Efficiency.
- Electronic Components.
- Flexibility.
- General Hse Knowledge.
- Good Documentation Practice.
- Installations (Computer Programs).
- Iso (International Organization For Standardization).
- Job Description.
- Knowledge Of Gmp.
- Lean Manufacturing.
- Manufacturing (Production).
- Manufacturing Process.
- Nuclear Medicine.
- Physics.
- Product Distribution.
- Production Line.
- Scheduler.
**Languages**:
- English.
Division
Operations
Business Unit
Innovative Medicines
Location
Mexico
Site
INSURGENTES
Company / Legal Entity
MX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.
Functional Area
Technical Operations
Job Type
Full time
Employment Type
Regular
Shift Work
No
**Accessibility and accommodation**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

📌 Documentation Specialist (Xico)
🏢 Novartis
📍 Xico