Job Summary:

A CDMO (Contract Development and Manufacturing Organization) Pharmaceutical Analytical Quality Assurance (AQA) role sits at the intersection of analytical science and quality systems. The focus is to ensure that all analytical testing (raw materials, in-process, finished products, stability, etc.) meets regulatory standards and is scientifically sound.

Key Responsibilities:

1. Analytical Method Oversight

Review and approve analytical methods (e.g., HPLC, GC, dissolution, spectroscopy).
Ensure methods are validated according to guidelines like ICH, FDA, ChP.
Assess method transfer activities between labs or sites.

2. Data Integrity& Review

Audit analytical data for accuracy, completeness, and compliance.
Ensure adherence to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate).
Review audit trails, chromatograms, spectra, and raw data for anomalies.

3. Quality Systems Compliance

Ensure compliance with Good Manufacturing Practices (GMP) (e.g., FDA, EMA)
Support regulatory inspections and client audits.
Review and maintain SOPs related to analytical activities.

4. Deviation, OOS & CAPA Management

Investigate:

OOS (Out-of-Specification) results
OOT (Out-of-Trend) data
Quality events

Lead or support root cause analysis.
Implement CAPA (Corrective and Preventive Actions).

5. Stability Program Oversight

Review stability protocols and reports.
Ensure studies follow ICH stability guidelines (e.g., ICH Q1).
Monitor trends for product shelf-life determination.

6. Documentation & Reporting

Review:

Certificates of Analysis (CoA)
Analytical reports
Validation protocols/reports

Ensure documentation is inspection ready.
Release of starting materials.

7. Vendor & Contract Lab Management

Qualify and audit external analytical labs.
Ensure third-party testing complies with GMP standards.

8. Cross-functional Collaboration

Work closely with:

Analytical Development
QC (Quality Control)
Manufacturing
Regulatory Affairs

Act as QA representative in project teams.

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Requiring Skills and Competencies:

Technical Skills

Strong understanding of analytical techniques (HPLC, GC, UV, IR, etc.)
Knowledge of method validation and transfer
Familiarity with pharmacopeia (USP, EP, JP)

Quality & Regulatory Knowledge

GMP, GLP, and data integrity requirements
Experience with regulatory submissions and audits

Soft Skills

Critical thinking and attention to detail
Strong documentation and communication skills
Problem-solving in deviation investigations

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Qualifications:

Degree or master's in pharmacy, Chemistry, Pharmaceutical Sciences, or related field.
QC, Analytical Development, or QA in pharma/CDMO environment.
Knowledge of cGMP, SOPs, and shop-floor QA activities.
Good documentation, communication, and coordination skills.

Senior Specialist – Analytical Quality Assurance (AQA)