Quality Control Officer

Role & responsibilities

1. JOB PURPOSE

To perform and coordinate chemical, physical and analytical quality-control testing of raw materials, packing materials, in-process materials, finished tablets and oral liquid/syrup products in accordance with approved specifications, analytical methods, pharmaceutical requirements, GMP procedures and company SOPs.

The position is responsible for generating accurate, reliable, traceable and timely analytical results and supporting QC/QA in the disposition and release of pharmaceutical products.

QC should operate independently from Production, with appropriate procedures, trained personnel, documented testing and controlled laboratory records.

2. KEY RESPONSIBILITIES

A. Raw Material Analysis

Perform sampling/testing of incoming pharmaceutical raw materials as per approved sampling plans and specifications.

Typical activities include:

• Identification testing of APIs and excipients.
• Assay/potency testing.
• Related substances/impurity testing where applicable.
• Loss on drying/moisture determination.
• pH determination where applicable.
• Melting point and other physical tests.
• Bulk density/tapped density where applicable.
• Particle-size analysis where specified.
• Water content/Karl Fischer where applicable.
• Organoleptic examination.
• Evaluation against approved pharmacopoeial/company specifications.
• Review supplier COA against internal requirements.
• Record and report analytical results accurately.

Specifications should define appropriate requirements for identity, content, purity and quality of materials and finished products.

3. TABLET QUALITY CONTROL

Conduct analysis of tablet products at in-process, bulk and finished-product stages.

Physical Tests

Perform, as applicable:

• Appearance/description
• Average weight
• Weight variation
• Thickness
• Diameter
• Hardness
• Friability
• Disintegration time
• Dissolution
• Uniformity of dosage units/content uniformity
• Moisture content
• Tablet dimensions
• Coating examination
• Visual defects

Chemical / Analytical Tests

• Identification of API
• Assay
• Related substances/degradation products
• Dissolution assay/profile where applicable
• Content uniformity
• pH where applicable
• Residual solvents where applicable
• Other product-specific tests as per specification

Testing shall be performed using approved and, where applicable, validated analytical procedures.

4. SYRUP / ORAL LIQUID ANALYSIS

Perform analytical testing of oral liquids/syrups throughout manufacturing and before final release.

Physical & Chemical Testing

Depending on the product specification:

• Appearance
• Colour
• Odour
• Clarity
• pH
• Specific gravity
• Viscosity
• Fill volume
• Assay of active ingredients
• Identification
• Related substances/degradation products
• Preservative content, where applicable
• Alcohol content, where applicable
• Sugar/solids content, where applicable
• Microbial quality testing coordination
• Container/closure compatibility checks where required

Special attention should be given to homogeneity, sampling and representativeness, particularly for suspensions or products where segregation may occur.

5. IN-PROCESS QUALITY CONTROL

Coordinate with Production for timely sampling and testing during manufacturing.

Tablets

Monitor, as applicable:

• Blend uniformity
• Granule moisture
• Granule characteristics
• Compression parameters
• Tablet weight
• Weight variation
• Hardness
• Thickness
• Friability
• Disintegration
• Coating parameters
• Appearance

Syrup / Oral Liquid

Monitor, as applicable:

• Raw material addition
• Mixing time
• Mixing speed
• Bulk appearance
• pH
• Specific gravity
• Viscosity
• Homogeneity
• Bulk volume
• Fill volume
• Appearance
• Intermediate-stage assay where required

Sampling plans should be designed to detect variability across the batch and relevant process stages

Preferred candidate profile

• Flight Ticket
• Food
• Accommodation
• Medical Benefits