JOB DESCRIPTION:

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.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

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