*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.