Senior Specialist – Analytical Quality Assurance (AQA)

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:

1. OOS (Out-of-Specification) results
2. OOT (Out-of-Trend) data
3. 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:

1. Certificates of Analysis (CoA)
2. Analytical reports
3. 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:

1. Analytical Development
2. QC (Quality Control)
3. Manufacturing
4. 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.