Analyst, Quality Assurance

Hikma Pharmaceuticals; Sintra; On-site; EUR 26,000 - 38,000; Full time

Benefits offered by this job

Direct Hikma contract

Life insurance

Children's health insurance

Annual bonus

Growth opportunities

Job summary

Hikma Pharmaceuticals in Portugal is seeking a QA Analyst to join the Quality Assurance Department on-site in a dynamic manufacturing environment.

The role involves conducting and verifying analyses, supporting in-process controls during filling, aseptic practices, and routine inspections to ensure compliance with cGMP and FDA standards. You will also train new QA analysts and review equipment data to ensure accuracy.

Qualifications

• High School Diploma or a Science degree.
• Ability to multi-task under tight deadlines.
• Attention to detail and flexibility.
• Fluent English and good computer skills.
• Knowledge of cGMP, FDA and regulatory standards.
• Willingness to work 8-hour rotating shifts.

Responsibilities

• Conduct or verify bulk sample analysis.
• Verify or conduct sampling and analysis during filling of batches.
• Conduct or verify analysis after cleaning of machine parts.
• Verify data in-process forms and LIMS daily.

Skills

Multi-tasking

Deadline driven

Attention to detail

English fluency

Computer skills

Regulatory knowledge

Education

High School Diploma

Science degree

Tools

LIMS

QC equipment

Job description

Founded by Samih Darwazah over 40 years ago in Jordan, Hikma's purpose is to provide affordable, quality medicines to the people who are competent. Based on very solid foundations, we continue to innovate daily and find practical solutions to transform the lives of the millions of people we serve.

At the end of the 1980s, we extended ours beyond the Middle East and acquired land in Portugal for the construction of a sterile factory for injectable pharmaceutical products. This was an important turning point for the company, and our first step into a new region. Today, in Portugal, we have more than 900 employees and 3 factories for the production of injectable medicines.

Hikma, intends to recruit an Analyst, Quality Assurance (m/f) to integrate Quality Assurance Department, on-site work.

Main Responsibilities

• Conducting or verifying analysis of bulk sample
• Verifying or conducting sampling and analysis of the in-process control during filling of the batches
• Conducting or verifying analysis after cleaning of machine production parts to verify clean conformity
• Verify or enter the data of the in-process forms/logbook/LIMS on a daily basis and check for accuracy upon request
• Ensures that the equipment's and solutions in use are maintained under validity
• Sample finished product to be tested by the Microbiology and Quality Control Departments
• Performs round checks in production departments, bulk packaging and infrastructures
• Performs inspections in the production areas whenever necessary
• Carries out the start-up before the beginning or during production (whenever necessary)
• Performs Aseptic Practices and Cleaning/ Disinfection Monitoring
• Samples and carries out acceptance procedures in all the different phases of the production, undertakes visual inspection by attributes for defects
• Approves maintenance requisitions for the release of production
• Trains new QA analyst
• Verifies print-outs from equipment related with productions activities

Profile

• High School Diploma or an Academic degree in Science
• Ability to handle a multi-task operation, to meet tight deadlines and to work under pressure
• Should be assertive, flexible, and attentive to detail
• Fluency in English and good computer skills are preferred
• Knowledge regarding the Injectables pharmaceutical industry, current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) and other regulatory authority requirements
• Availability to work 8-hour shifts with rotating days off

We Offer

• Direct contract with Hikma
• Competitive salary aligned with the role
• Life insurance
• Health Insurance extended to student children (up to age 24)
• Annual Performance Bonus
• Real Growth Opportunities