Chemical Manager

Abbott


Date: 7 hours ago
City: Karachi
Contract type: Full time
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.

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