Job Description

At Julphar, we are on a journey of culture transformation & our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism.


Our core values: Respect, Collaboration, innovation, Integrity and Compassion - Combined with a focus on diversity, inclusion, and equal opportunities - are key drivers in our aim to make a positive impact on the lives of the patients we serve, enable Talents , create a healthy work environment, and accomplish our goals through world-class research and with the compassion and commitment of our employees.

Main Responsibilities

Prepare, review, and oversee

process and cleaning validation documentation

and execution activities for

Sterile Facilities

, including

Liquid Injectables, Lyophilized products, and Sterile Powder Filling

. Conduct

process validation

for various dosage forms such as

Oral Solid Dosage (Tablets, Capsules, PPS)

,

Oral Liquids (Syrups, Suspensions, Oral Drops)

, and

Semi-Solids (Ointments, Creams, Suppositories)

. Manage

process validation activities

for

API biological drug substances

and

sterile products

. Demonstrate familiarity with

filter validation requirements

in sterile areas. Design and execute

Aseptic Process Simulation (APS)

studies, including preparation of related

protocols and reports

. Lead the

visual inspection qualification process

. Manage

shipping validation

activities for

cold chain products

. Oversee

cleaning validation activities

, including

dirty equipment hold-time studies

. Review and support

Change Controls, CAPAs, and Deviations

associated with qualification and validation activities. Act as

Quality General

in EQMS to complete actions related to qualification and validation. Monitor and verify

CAPA effectiveness

related to validation activities.

Core Competencies

---------------------


Strong

results orientation

with a high level of

accountability and ownership

. Ability to

prioritize, multitask, and perform effectively

under pressure to meet deadlines. Excellent

communication, interpersonal, and collaboration skills

. Highly

disciplined, organized

, and

self-motivated

to learn and implement new practices. Proven

technical expertise

in

qualification and validation

within

sterile and biotech facilities

. Strong

implementation skills

with adaptability to changing business requirements. Ability to work effectively in

cross-functional environments

, collaborating with internal and external stakeholders. Strong capability to

communicate technical, scientific, and regulatory information

clearly--both verbally and in writing.

Qualification & Functional Knowledge

-----------------------------------------

Education:

Bachelor's degree in

Pharmacy or Science

.

Experience:

Minimum

3-5 years

of relevant experience in qualification and validation within the pharmaceutical/biotech industry. Hands-on experience with

regulatory audits

(SFDA, WHO, EU, USFDA). Strong working knowledge of

QMS systems

such as Agile, Veeva Vault, TrackWise, and AmpleLogic*.
Excellent

computer proficiency

and

command of English

(written and spoken). Demonstrated

problem-solving and team coordination

skills. Solid understanding of

cGMP principles

and

Risk Assessment

methodologies.
We value people from different backgrounds. Could this be your story? Apply today or visit www.Julphar.net to read more about us and the journey of Julphar