Executive

Department: Quality Control  

Location:  Lupin Mandideep 

Experience Required: 3 to 8 years in Pharmaceutical Quality Control  

Employment Type: On roll 

Job Summary:  

We are seeking an experienced Quality Control Professional with  3-8 years of experience in the pharmaceutical industry and hands-on expertise in LIMS (LabWare) implementation, configuration, and validation. The ideal candidate will ensure compliance with cGMP, FDA, and other regulatory standards while supporting QC operations and digital lab solutions.  

Key Responsibilities:

- Lead or support LIMS (LabWare) implementation, customization, and validation in the QC lab.  

- Ensure data integrity, electronic record compliance (21 CFR Part 11), and system troubleshooting.  

- Develop and review SOPs, test methods, and validation protocols related to LIMS and analytical processes.  

- Collaborate with IT, QA, and validation teams for system upgrades, change controls, and audits.  

- Train QC personnel on LIMS functionality and best practices.  

- Participate in regulatory inspections and internal audits.  

- Support OOS/OOT investigations, deviations, and CAPA implementation.  

Qualifications & Skills:

- Bachelors/Master’s degree in Pharmacy, Chemistry, Microbiology, or related field.  

- 3-8 years of hands-on experience in Pharmaceutical Quality Control.  

- Proven experience in LIMS (LabWare) implementation, configuration, and validation is a must.  

- Strong knowledge of cGMP, FDA/EMA/ICH guidelines, and analytical techniques (HPLC, GC, Dissolution, etc.).  

- Familiarity with 21 CFR Part 11, data integrity principles, and electronic lab systems.  

- Excellent problem-solving, documentation, and communication skills.  

Preferred (Not Mandatory)  

- Experience with other LIMS systems (e.g., STARLIMS, LabVantage).  

- Knowledge of statistical tools (e.g., Minitab) and method validation/transfer.