PRODUCTION SPECIALIST

Gensenta İlaç; Bahçelievler; On-site; TRY 120,000 - 180,000; Full time

Benefits offered by this job

Training programs

Rotation among 50+ companies

Hybrid work options

Nursery support for new parents

Paternity leave

Cultural access to Istanbul Modern

Volunteer opportunities

Equal opportunity employer

Job summary

Gensenta İlaç, among Turkey's oldest pharmaceutical companies, continues to lead with sterile manufacturing excellence and cGMP compliance across operations.

The role seeks a bio/chemical engineer or chemist with 2+ years in aseptic pharma, strong GMP knowledge, English proficiency, and experience with SAP or Werum PAS-X; join our OpEx culture and drive continuous improvement in the cleanroom environment.

Qualifications

• Bachelor’s degree in Bioengineering, Chemical Engineering, Chemistry, Pharmacy, or related field.
• At least 2 years in a sterile/aseptic pharmaceutical manufacturing role with GMP understanding.
• Knowledge of contamination control, cleanroom classifications, and aseptic processing principles.
• Advanced English proficiency.

Responsibilities

• Ensure operations and product quality comply with cGMP, Health regulations, and EHS policies, with focus on sterile manufacturing.
• Ensure all GxP activities comply with Data Integrity principles.
• Monitor aseptic techniques, gowning, and cleanroom behavior in graded areas.
• Perform Environmental Monitoring activities and trend results.
• Participate in Operational Excellence (OpEx) and continuous improvement initiatives.
• Support deviation investigations related to environmental excursions and sterility.
• Monitor sterile manufacturing activities per production plan (filling, lyophilization, sterilization).
• Support media fill studies and verify Batch/ Master records for compliance.

Skills

GMP knowledge

Data integrity

Aseptic processing

Cleanroom discipline

SAP

Werum PAS-X

English proficiency

MS Office

Proactive communication

Education

Bachelor's degree in Bioengineering/ Chemical Engineering/ Chemistry/ Pharmacy

Tools

SAP

Werum PAS-X

Job description

Gensenta, one of Turkey's leading, oldest, and most established pharmaceutical companies, has been serving public health for nearly a century. With its renewed identity in 2020, the company is working towards providing broader geographical coverage, serving more patients, and offering new and comprehensive solutions, all while facilitating patient access to medication. Also export to the region that constitutes 70% of the global pharmaceutical market through Turkey. As of November 2022, we continue our operations as one of the establishments within the Eczacıbaşı Group.

What do we expect from our new team member?

• Ensure that operations and product quality comply with current Good Manufacturing Practices (cGMP), Ministry of Health regulations, and Environmental, Health & Safety (EHS) policies, with particular focus on sterile manufacturing requirements.
• Ensure that all GxP activities are conducted in compliance with Data Integrity principles.
• Monitor and ensure compliance with aseptic techniques, gowning qualification requirements, and cleanroom behavior standards in classified areas (Grade A/B/C/D).
• Perform Environmental Monitoring (EM) activities and ensure timely trending and evaluation of monitoring results.
• Actively participate in Operational Excellence (OpEx), productivity, and continuous improvement initiatives.
• Participate in deviation investigations, including those related to environmental excursions and sterility assurance.
• Monitor manufacturing activities for sterile products in line with the production plan (e.g., filling, lyophilization, terminal sterilization, where applicable).
• Support and/or participate in media fill (aseptic process simulation) studies.
• Verify that Batch Production Records (BPR/MBR) are completed accurately, comprehensively, and in compliance with sterile manufacturing requirements.
• Prepare and update Master Batch Records (MBRs), Standard Operating Procedures (SOPs), forms, and related documentation in line with approved changes.
• Train operators on updated procedures, aseptic practices, and contamination control requirements.
• Contribute to continuous improvement initiatives within the sterile manufacturing area.

What kind of teammate are we looking for?

• Bachelor's degree in Bioengineering, Chemical Engineering, Chemistry, Pharmacy, or a related Engineering discipline.
• Minimum of 2 years of experience in a similar role within sterile/aseptic pharmaceutical manufacturing, with a solid understanding of GMP requirements.
• Knowledge of contamination control strategies, cleanroom classifications, and aseptic processing principles.
• Preferably experienced with SAP and Werum PAS-X systems.
• Advanced level of English proficiency.
• Proficiency in Microsoft Office applications.
• Proactive, solution-oriented, and possessing strong communication skills.
• Committed to continuous improvement and operational excellence.

What Do We Offer You?

• At Eczacıbaşı, you can steadily improve your personal, professional, and technical competencies by participating in training programs that support you and your career.
• You will have access to opportunities for rotation among more than 50 companies and global experience in over 120 international markets.
• Vacation time at Eczacıbaşı is calculated according to seniority based on your total work experience. Your bring your seniority with you.
• We will always recognize your success through different reward methods.
• You can take advantage of location-independent or hybrid work opportunities through different work models suitable to the nature of your job, and you can determine your own work schedule with flexible work hours. We offer technology and ergonomic support packages to Eczacıbaşı employees who work remotely full-time.
• As a new parent working at Eczacıbaşı, you are privileged. Eczacıbaşı employees who are mothers are provided with monthly nursery support; Eczacıbaşı employees who are fathers are entitled to a 3-week paternity leave.
• People who savor culture and art are here! Thanks to the Eczacıbaşı Group’s founding sponsorship of Istanbul Modern, Turkey's first modern and contemporary art museum, you can visit the museum for free. Additionally, thanks to Eczacıbaşı Group’s founding sponsorship of Istanbul Foundation for Culture and Arts (İKSV), you can also enjoy the privilege and discounts of İKSV’s Lale Card to all İKSV events.
• You can participate in Eczacıbaşı’s volunteering activities, every one of which prioritizes social benefit, and get involved in projects that create social impact.

We are committed to ensuring equal opportunity of employment. We value diversity and do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status or seniority.

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