Department
Health & Biotech
Category
Health & Biotech
Job type
Full-Time
Experience
3 Years
Description
- Lead complex investigations and create effective project plans to ensure timely closure, engaging site Subject Matter Experts (SMEs), managing meetings, and reporting investigation updates to key personnel across the site.
- Serve as an Operations technical SME in cross-functional Method 1 (M1) investigations.
- Utilize Six Sigma investigation tools, including MiniTab, Fishbone, and 5 Whys methodologies, for true root cause identification and effective CAPA implementation.
- Drive timely closure and quality improvements to reduce repeat deviations, increase performance, and reduce waste and costs.
- Proactively engage with Operations staff to identify CI initiatives, focusing on safety, quality, compliance, and Materials Usage Variance (MUV)/cost reduction.
- Provide continued education and mentoring to Operations staff on the importance of proactive data analysis, investigation methods, CI identification, and root cause and CAPA determination, fostering a positive working environment and resilience.
- Initiate and deliver Change Controls (CC) related to CAPAs and CI initiatives, ensuring timely closures.
- Present Operations investigation findings during Regulatory inspections and Contract Customer Audits.
- Monitor and report deviation performance metrics as directed.
- Perform any other duties as assigned by the Production Compliance Lead.
Qualifications
Highest qualification: University
- Bachelor’s degree in science, Pharmacy, Engineering, or a related discipline, or equivalent experience in the pharmaceutical or allied industry.
- 3-5 years of experience in pharmaceutical manufacturing/Quality.
- 1-3 years of experience in facilitating investigations using Six Sigma tools, Fishbone, and 5 Whys methodologies for root cause analysis and effective CAPA identification.
- Knowledge and application of Good Manufacturing Practices (cGMP).
- Experience with compliance issues resulting from cGMP deviations or product defects.
- Exceptional communication, negotiation, interpersonal, and leadership skills (both verbal and written).
- Results-focused with demonstrated Project Management skills, the ability to manage multiple projects, and meet business targets and delivery timelines.
- Attention to detail, technical knowledge, innovative thinking, and problem-solving abilities, including implementation of resolutions.
- Ability to work under pressure and meet agreed timelines with high attention to detail.