Laboratory Validation Chemist

at  Cipla

Benoni, Gauteng, South Africa -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate25 Dec, 2024Not Specified01 Oct, 20244 year(s) or aboveGood communication skillsNoNo
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Description:

KEY ACCOUNTABILITIES (1/5)

  • Provides support to quality control and manufacturing for resolution of analytical and quality related problems
  • Works on Tech transfer projects.
  • Responsible for ensuring GAP analysis and risk assessments are submitted on time for tech transfer products
  • Drafts all protocols related to Analytical method development, method transfer, cleaning validation methods and method verification.
  • Prepares tracker for AMD, AMV and AMT to be performed and report on progress on Monthly basis.
  • Execute all protocols as per plan and tracker.
  • Ensure staff is trained on the procedures.
  • Logs CAPA, Deviations and Change controls and ensure they closed within stipulated time frame.
  • Implements activities to prevent recurring of OOS and OOT attributed to QC function
  • Trouble shooting
  • Responsible for ensuring the integrity of all data and documentation reported from the Chemistry Laboratory.
  • Reviews all source data for conformance to applicable specifications.
  • Facilitates data or documentation corrections with analysts to ensure all records are complete and appropriate references are made.
  • Ensures investigations are assigned, completed and referenced for data or documentation, as appropriate, prior to release of Chemistry data.
  • Interacts routinely with departments such as Production, RA, R&D, QA Validation team
  • Assist in performing Quality Assurance audits on laboratory areas to ensure cGMP compliance.
  • Assist in the investigation and review of deviation reports and OOS reports to assure complete and compliant source data.
  • Assist in training and mentoring junior analysts on the interpretation of data and use of electronic data systems.

EDUCATION QUALIFICATION

National Diploma / BTech Degree and or B.Sc. in Analytical Chemistry/Biotechnology

RELEVANT WORK EXPERIENCE

4-7 years in a laboratory environment

Responsibilities:

The incumbent is responsible for planning, drafting protocols, execution and final reporting approval of Analytical Method validation (AMV), Analytical Method transfer (AMT) and Process Validation (PV) / special request (non-routine) samples in accordance with procedure.


REQUIREMENT SUMMARY

Min:4.0Max:7.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Diploma

Proficient

1

Benoni, Gauteng, South Africa