Pharma Excipients Technical Qualification Manager – Saudi Arabia
Palomba General Trading
Role:Pharma Excipients Technical Qualification Manager – Saudi Arabia
Location: Jeddah, Saudi Arabia
Employment Type: Full-time
Workplace: Hybrid / Technical & Customer-facing
Regional Scope: Saudi Arabia | Selected GCC Projects
Travel: Regular travel within Saudi Arabia
Palomba General Trading LLC is seeking an experienced Pharma Excipients Technical Qualification Manager to support the technical approval and qualification of pharmaceutical excipients with manufacturers across Saudi Arabia.
This role sits between the excipient manufacturer and the pharmaceutical customer.
The objective is not simply to provide a specification sheet.
The successful candidate will determine whether an excipient can realistically pass the technical, quality and documentation requirements necessary to become an approved raw material at the customer.
Core MissionThe role will manage the technical qualification path:
Supplier Product → Technical Documentation Review → Specification Comparison → Customer Evaluation → Qualification Questions → Sample / Trial → Approval
The position will support pharmaceutical manufacturers evaluating new or alternative excipient sources.
Key Responsibilities
Manage technical qualification projects for pharmaceutical excipients.
Review supplier specifications before customer submission.
Compare proposed excipient grades against customer specifications.
Coordinate CoA, TDS, SDS and quality documentation.
Support customer technical questionnaires.
Coordinate documentation requests with international manufacturers.
Identify missing information before formal customer qualification.
Review pharmacopoeial and compendial requirements.
Support alternative-source qualification projects.
Coordinate samples and representative batch documentation.
Follow technical questions from Quality, R&D and Procurement teams.
Support deviation and specification-gap discussions.
Coordinate responses related to manufacturing process and raw-material controls.
Support documentation required for supplier approval.
Follow qualification projects through technical closure.
Maintain structured records of qualification status and outstanding documentation.
Excipient CategoriesQualification projects may involve:
Microcrystalline Cellulose
Lactose
Mannitol
Sorbitol
Calcium Phosphates
Pharmaceutical Starches
Pregelatinized Starch
Croscarmellose Sodium
Crospovidone
Sodium Starch Glycolate
Povidone
HPMC
HPC
Magnesium Stearate
Stearic Acid
Colloidal Silicon Dioxide
Talc
Cyclodextrins
Coating excipients
Functional excipient systems
Technical Documentation FocusThe candidate should be comfortable reviewing and coordinating documentation such as:
Product specifications
Certificate of Analysis
Technical Data Sheet
Safety Data Sheet
Pharmacopoeial compliance
Manufacturing site information
GMP-related documentation
Allergen statements where applicable
GMO statements
TSE/BSE declarations
Residual solvent information
Elemental impurity information
Microbiological specifications
Stability information
Shelf life
Packaging specifications
Country of origin
Manufacturing-flow information
Change-control procedures
Compendial KnowledgeExperience with major pharmaceutical standards is highly valued, including:
USP/NF
Ph. Eur.
BP
JP
relevant harmonised monographs
The candidate should understand that meeting a product name on paper does not automatically mean two excipient grades are technically interchangeable.
Customer QualificationThe role will work directly with:
Quality Assurance
Quality Control
Regulatory Affairs
R&D
Formulation
Procurement
Supply Chain
Typical customer questions may include:
Does the proposed grade comply with our pharmacopoeial requirement?
Are particle size and bulk density comparable?
Is the manufacturing process equivalent?
Is the material sourced from the same type of raw material?
Are impurity limits acceptable?
Can the supplier guarantee batch consistency?
What change-control system is in place?
Is stability data available?
What documentation can support regulatory filing?
Can the supplier support audits or technical questionnaires?
Alternative Source QualificationAn important part of the role will be supporting pharmaceutical manufacturers seeking:
second-source qualification;
replacement of an existing supplier;
cost optimisation;
supply-chain risk reduction;
alternative manufacturing origins;
improved lead times;
additional qualified capacity.
The candidate should evaluate whether the proposed alternative is technically credible before commercial resources are committed.
Supplier InteractionThe successful candidate will also work closely with international excipient manufacturers to:
clarify technical questions;
obtain missing documents;
coordinate updated specifications;
answer customer questionnaires;
support qualification documentation;
manage customer feedback;
improve supplier readiness for GCC customers.
Candidate Profile
5+ years in Pharmaceutical Excipients, Pharmaceutical Quality, Raw-Material Qualification, Supplier Quality or related areas.
Degree in Pharmacy, Pharmaceutical Sciences, Chemistry or related discipline preferred.
Strong understanding of pharmaceutical raw-material specifications.
Experience reviewing technical documentation.
Familiarity with pharmacopeial requirements.
Experience dealing with pharmaceutical manufacturers.
Knowledge of supplier qualification processes.
Ability to communicate effectively with international manufacturers.
Saudi pharmaceutical industry experience strongly preferred.
Fluent English required.
Arabic is an advantage.
Ideal BackgroundRelevant candidates may currently work as:
Raw Material Qualification Manager
Supplier Quality Manager
Pharmaceutical Excipients Technical Manager
QA Raw Materials Manager
Vendor Qualification Specialist
Pharmaceutical Technical Documentation Manager
Excipients Quality Specialist
Technical Product Qualification Manager
Supplier Quality Assurance Manager
What We Offer
Competitive fixed salary.
Performance-based bonus.
Responsibility for Saudi pharmaceutical qualification projects.
Direct interaction with international excipient manufacturers.
Exposure to leading pharmaceutical manufacturers.
Opportunity to help build the PGT Middle East excipients platform.
High degree of technical autonomy.
Participation in supplier and product-selection decisions.
Who We Are Looking ForWe are looking for someone who sees a supplier specification and does not immediately conclude:
“The product name is the same, so it should be fine.”
The candidate should instead ask:
Which pharmacopeia applies?
Are the analytical limits really comparable?
Is particle size equivalent?
Is bulk density important for this formulation?
What is the manufacturing process?
What impurity controls exist?
Can the supplier provide appropriate documentation?
What will QA ask?
What will Regulatory ask?
Can this product realistically become an approved second source?
The objective is to reduce wasted qualification projects and ensure that only technically credible excipient alternatives are presented to pharmaceutical customers.