Job Description

Department: Corporate Laboratories Excellence

Function: Stability Studies

Job Level: Corporate Lead

Reports To: Corporate Laboratories Excellence Manager

Industry: Pharmaceutical Manufacturing

1. Job Purpose

To lead, manage, and ensure effective execution of the Quality Control Stability Program in compliance with GMP, ICH, and regulatory requirements. The role is accountable for stability study design, execution, monitoring, data evaluation, and reporting to ensure ongoing product quality, shelf-life justification, and regulatory compliance throughout the product lifecycle.

The Corporate Lead role is expected to operate at a technical governance and strategic level, overseeing the related function across seven sites, with responsibility extending beyond operational execution.

2. Key Responsibilities

A. Stability Program Leadership

• Lead 7 sites stability program in line with ICH Q1 guidelines and regulatory commitments.
• Ensure stability studies are initiated, maintained, and closed as per approved protocols and registration requirements.
• Own the stability master plan and ensure alignment with regulatory filings and lifecycle changes.
• Coordinate stability activities for new products, variations, site transfers, and post-approval changes.

B. Stability Study Management

• Review and approve stability protocols, reports, and trending summaries.
• Ensure appropriate pull schedules, sample storage, labeling, and tracking.
• Monitor on-time testing and data availability according to approved timelines.
• Manage stability chambers (qualification, mapping, monitoring, alarms, excursions).

C. Data Review, Trending & Reporting

• Review and approve stability test results for compliance with specifications.
• Perform trend analysis and statistical evaluation to identify potential quality risks.
• Investigate out-of-trend (OOT), out-of-specification (OOS), and atypical results related to stability.
• Prepare stability summaries for regulatory submissions, annual product reviews (PQR/APR), and inspections.

D. Compliance & GMP Assurance

• Ensure stability activities comply with GMP, data integrity (ALCOA+), and site SOPs.
• Maintain inspection-ready stability documentation and records.
• Support internal, customer, and regulatory audits; act as stability SME during inspections.
• Ensure proper change control, deviation management, and CAPA implementation related to stability.

E. Cross-Functional Coordination

• Collaborate with QA, Regulatory Affairs, Production, Packaging, and R&D.
• Provide stability input for shelf-life assignment, re-test periods, and storage conditions.
• Support product launch readiness and lifecycle management activities.

F. Team Leadership & Development

• Lead and mentor stability analysts and specialists.
• Assign workload, review performance, and support competency development.
• Ensure team adherence to GMP and safety requirements.

G. Corporate Role

• Technical oversight of the related function across all sites, ensuring consistent performance and harmonization.
• Development and execution of short-term improvement initiatives and long-term strategic plans addressing:
• Quality of outputs
• GMP and Data Integrity compliance against stringent regulatory requirements
• Reduction of waste (time, materials, resources, and cost).
• Continuous improvement and optimization of related processes and workflows.
• Manpower planning and budget forecasting at the corporate level.
• CapEx and OpEx planning, justification, and prioritization for the related function.
• Leadership and technical oversight of critical OOS, OOT, and major deviation investigations.
• Planning and execution of intercompany audits and follow-up of corrective actions.
• Leadership of corporate-level projects related to the assigned function.
• Development, monitoring, and governance of KPIs for the related function across all sites.
• Technical review and approval of CTD-related sections relevant to the function.

3. Qualifications

• Bachelor’s degree in pharmacy, Chemistry, Pharmaceutical Sciences, or related field.
• Postgraduate qualification is an advantage.
• 6–10 years of QC experience, with strong focus on stability studies in pharmaceutical manufacturing.

4. Technical Skills & Knowledge

• Strong knowledge of ICH Q1A–Q1E, GMP, and regulatory stability requirements.
• Experience with stability chambers qualification and monitoring systems.
• Solid understanding of analytical testing methods and validation principles.
• Experience in OOS/OOT investigations and trend analysis.
• Familiarity with electronic systems (LIMS, Stability Management Systems).

5. Behavioral Competencies

• Quality mindset & compliance orientation.
• Analytical thinking & risk assessment.
• Accuracy and attention to detail.
• Leadership & coaching skills.
• Strong communication and cross-functional collaboration.

6. Key Performance Indicators (KPIs)

• On-time completion of stability pulls and testing.
• Stability data compliance and audit outcomes.
• Timely closure of OOS/OOT and deviations.
• Inspection readiness and regulatory findings.
• Team performance and competency development.

Requirements added by the job poster

• Bachelor’s Degree

• 10+ years of work experience with Pharmaceutical Manufacturing

• Master’s Degree