مدير التأهيل الفني للسواغات الصيدلانية – المملكة العربية السعودية

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 Mission

The 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 Categories

Qualification 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 Focus

The 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 Knowledge

Experience 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 Qualification

The 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 Qualification

An 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 Interaction

The 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 Background

Relevant 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 For

We 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.