Description

Job Description

Department: Corporate Laboratories Excellence

Function: Raw Materials & Packaging Materials

Job Level: Corporate Lead

Reports To: Corporate Laboratories Excellence Manager

Industry: Pharmaceutical Manufacturing

1. Job Purpose

To lead and oversee Quality Control activities related to Raw Materials and primary packaging materials, ensuring timely testing, approval, and release in compliance with GMP, pharmacopeial standards, and regulatory requirements. The role ensures material quality, supply continuity, and inspection readiness throughout the material 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. Raw Material QC Leadership

Lead QC activities for raw materials (APIs, excipients, solvents).

Ensure effective sampling, testing, review, and approval of incoming materials in line with approved specifications and pharmacopeias (USP, EP, BP, JP).

Oversee material release timelines to support uninterrupted manufacturing operations.

B. Testing, Review & Approval

Review and approve raw material test results, CoAs, and analytical data.

Ensure appropriate testing strategies (full testing, reduced testing, skip-lot where applicable).

Ensure compliance with approved specifications, analytical methods, and sampling plans.

C. Compliance & GMP Assurance

Ensure all QC raw material activities comply with GMP, data integrity (ALCOA+), and site SOPs.

Maintain inspection-ready documentation for material testing and release.

Act as Subject Matter Expert (SME) during regulatory inspections and audits.

Support risk assessments related to raw material quality and supply.

D. Deviation, OOS & Change Management

Lead or support investigations for OOS, OOT, and deviations related to raw materials.

Assess impact of raw material issues on in-process and finished products.

Support change control activities related to material suppliers, specifications, and analytical methods.

Ensure timely and effective CAPA implementation.

E. Supplier & Cross-Functional Collaboration

Work closely with QA, Procurement, Supply Chain, Warehouse, and Regulatory Affairs.

Support supplier qualification, re-qualification, and technical evaluations.

Participate in vendor audits and supplier performance reviews.

Provide QC input for new material qualification and alternate supplier introduction.

F. Team Leadership & Development

Lead, coach, and develop raw material analysts and specialists.

Allocate workload, review testing performance, and ensure GMP compliance.

Identify training needs and support competency development of the team.

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

Improve testing efficiency, lead time reduction, and cost optimization without compromising quality.

Support implementation of LIMS and digital QC systems.

Participate in method optimization and laboratory excellence initiatives.

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 degree is an advantage.

6–10 years of experience in Quality Control within pharmaceutical manufacturing, with strong exposure to raw materials and packaging materials.

4. Technical Skills & Knowledge

Strong knowledge of GMP and pharmacopeial requirements (USP, EP, BP).

Expertise in raw material sampling, testing, and release processes.

Solid understanding of analytical techniques (HPLC, GC, IR, UV, wet chemistry).

Experience with OOS/OOT investigations and risk assessments.

Familiarity with LIMS and electronic documentation systems.

5. Behavioral Competencies

Quality mindset & compliance orientation.

Analytical thinking & problem-solving.

Accuracy and attention to detail.

Leadership and team management skills.

Strong communication and stakeholder coordination.

6. Key Performance Indicators (KPIs)

Raw material testing and release turnaround time.

OOS/OOT rate and investigation effectiveness.

Audit and inspection outcomes.

On-time supplier qualification support.

Team productivity and training compliance.