To lead, manage and monitor the Finished good section. To oversee the EHS and Quality Compliance of the lab.

Major Responsibilities:

• Monitor FG release on time. • Monitor zero stockouts caused by QC delays (monthly). • Manage and monitor to qualify new instruments. • Prevent team failures through structured leadership. • Define roles, workloads, and cross-coverage; maintain a skills matrix. • Conduct routine tier meetings (Tier-1 daily, Tier-2 weekly, Tier-3 monthly). • Coach on data integrity, OOS/OOT, safety, and problem solving. • Zero compromise on compliance and data integrity. • Enforce ALCOA+ principles across paper and electronic records. • Review and approve SOPs, STMs, specifications, and logbooks; ensure version control. • Ensure validated computerized systems and controlled access. • Conduct internal audits; close CAPAs on time. • Audit/inspection observations: zero critical, minimal major; 100% CAPA closure on time. • 100% adherence to document control and data integrity requirements. • Cascade departmental goals to individual SMART goals. • Monitor KPIs via dashboards; take corrective actions monthly. • Structured performance management and development. • Conduct goal setting at start of year; mid-year and year-end reviews. • Identify training needs and succession plans for critical roles. • Embed safety and environmental stewardship in Finished good section • Track and deliver EHS goals for QAD; participate in EHS audits and inspections. • Conduct chemical risk assessments, waste segregation, and proper disposal. • Report NMPI (Near Miss/Proactive Indicator) and close actions. • Zero lost-time incidents; 100% EHS training completion; near-miss reporting rate trending upward (positive culture). • Rapid resolution of analytical issues to protect supply and compliance. • Lead troubleshooting using scientific methods; document hypotheses, trials, and conclusions. • Engage OEMs for complex instrument issues; maintain service contracts and spares. • Facilitate method robustness improvements (system suitability, ruggedness). • Ensure integrity of all reported data and decisions. • Oversee vendor qualification testing and periodic supplier re-evaluation. • Govern OOS/LIR investigations per SOP; ensure root-cause depth and effective CAPAs. • Support Process Validation analytics (PPQ sampling plans, acceptance criteria). • Oversee CSV/GxP systems validation with QA/IT; manage change controls. • Represent QC in cross-functional forums, Quality Council, Change Review Board). • Approve urgent documents within delegated authority; manage crises and recalls with QA. • No disruption during delegation; timely decisions and communications recorded.

Education/Knowledge & Experience:

• M.Sc. Chemistry / Pharm-D • 8-10 years’ experience in the same capacity • Knowledge of requirement for QC/QA and all other activities taking place in QC/QA including knowledge of Annual product quality review.