Chemical Manager

Abbott; Pakistan; Vor Ort; PKR 1.800.000 - 3.000.000; Vollzeit

Zusammenfassung

Abbott in Pakistan (Karachi) seeks a senior QA/QC leader to manage the Finished Good section, oversee EHS and Quality Compliance, and drive continuous improvement. The role requires ensuring timely FG release, zero stockouts due to QC delays, and rigorous data integrity across paper and electronic records.

The candidate should have a Master’s in Chemistry or Pharm-D with 8–10 years’ experience in QC/QA, including knowledge of Annual Product Quality Review, SOPs, and audit readiness.

Qualifikationen

• M.Sc. Chemistry / Pharm-D
• 8-10 years' experience in the same capacity
• Knowledge of QC/QA and activities in QC/QA including Annual Product Quality Review

Aufgaben

• Lead Finished Good section and oversee EHS and Quality Compliance.
• Monitor FG release on time and ensure zero QC-related stockouts.
• Audit/inspect processes, manage CAPAs, and ensure data integrity and compliant documentation.

Ausbildung

M.Sc. Chemistry / Pharm-D

Jobbeschreibung

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

JOB FAMILY: Operations Quality

DIVISION: EPD Established Pharma

LOCATION: Pakistan > Karachi : Opp: Radio Pakistan Transmission, Hyderabad Road, Landhi

ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

TRAVEL: Not specified

MEDICAL SURVEILLANCE: Not Applicable

SIGNIFICANT WORK ACTIVITIES: Not Applicable