About this role
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.