Senior Team Leader - Manufacturing

Role & responsibilities

1. Independently handle the (QMS) change control, Risk Assessment, Deviation, Investigation, CAPA implementation, OOS, OOT, OOL Investigation, Process validation Protocol and report preparation, Internal and external audit compliance.
2. Candidate having technical knowledge injectable manufacturing and water system.
3. Knowledge of QMS Standards: Familiarity with ISO 9001, AS9100, or other relevant standards is essential.
4. Internal & External Auditing: Ability to conduct audits, prepare reports, and ensure corrective actions are implemented.
5. Process Improvement Tools: Proficiency in Six Sigma, Lean, and Total Quality Management (TQM) methodologies.
6. Quality Core Tools: Expertise in APQP, PPAP, FMEA, MSA, SPC, and Control Plans is highly valuable in manufacturing and product development.
7. Standard Operating Procedures (SOPs): Ability to create, maintain, and enforce SOPs across departments.
8. Clear Communication: Conveying quality expectations and findings to teams, stakeholders, and clients.
9. Training & Development: Sharing knowledge and mentoring others on quality practices and standards.
10. Team Collaboration: Working cross-functionally with production, engineering, and customer service teams.
11. Leadership: Inspiring teams to uphold quality standards and drive continuous improvement
12. Data Analysis: Skill in interpreting quality metrics, trends, and KPIs to identify areas for improvement.
13. Root Cause Analysis: Using tools like 5 Whys or Fishbone diagrams to diagnose and resolve quality issues.
14. Decision Making: Making fact-based decisions to maintain compliance and improve performance.
15. Clear Communication: Conveying quality expectations and findings to teams, stakeholders, and clients.
16. Training & Development: Sharing knowledge and mentoring others on quality practices and standards.
17. Team Collaboration: Working cross-functionally with production, engineering, and customer service teams.
18. Candidate having the qualification B Pharmacy, M pharmacy with good communication and Document writing skills.

Preferred candidate profile

Injectable experience

interested can send cv at Rashmi.kulkarni1@fresenius-kabi.com