Full-Time
Quality Assurance Specialist
Zentiva
1,001-5,000 employees
Produces branded generic pharmaceuticals in Europe
No salary listed
Ankleshwar, Gujarat, India
In Person
Bachelor's
 Biology & Biotech (1) |
|---|
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- A university degree in Pharmacy, Chemistry, Biology, or a relevant Life Science field.
- Knowledge of pharmaceutical GxP regulations and quality systems.
- Strong understanding of Good Distribution Practice principles and the European Union Good Distribution Practice Guidelines.
- Experience in pharmaceutical quality systems or supply chain compliance.
- Experience working in dynamic, transformational environments.
- Ability to coordinate external service providers and internal stakeholders.
- Strong documentation and organizational skills.
- Very good communication skills and a customer-oriented approach.
- Flexibility and ability to manage competing priorities.
- High autonomy, stress resistance, and a sense of urgency.
- A hands-on, flexible, adaptable, and open-minded approach.
- Knowledge of Microsoft applications and general computer skills.
- Advanced knowledge of English.
- Support maintenance of the Dutch Wholesale Distribution Authorization license in collaboration with the external Responsible Person service provider.
- Ensure all documentation required for Wholesale Distribution Authorization compliance is complete, current, and accessible.
- Coordinate internal inputs required for initial and ongoing Wholesale Distribution Authorization obligations.
- Maintain an overview of licensed activities and scope under the Wholesale Distribution Authorization.
- Act as the primary internal contact for the external Responsible Person and Wholesale Distribution Authorization service provider.
- Ensure timely exchange of information between Zentiva and the Responsible Person.
- Coordinate review and routing of Good Distribution Practice-relevant documents requiring Responsible Person approval.
- Track actions, commitments, and deliverables from the external provider.
- Ensure alignment of local Netherlands processes with Zentiva’s global Quality Management System.
- Support implementation and maintenance of Good Distribution Practice-related standard operating procedures.
- Coordinate document control activities related to the Wholesale Distribution Authorization scope.
- Ensure training records and Good Distribution Practice compliance documentation are maintained.
- Manage end-to-end complaints and deviation processes, ensuring accurate recording in Quality Forward and timely communication with manufacturing sites or External Supply Operations.
- Coordinate intake and tracking of Good Distribution Practice-relevant deviations and corrective and preventive actions.
- Ensure proper escalation to the Responsible Person and corporate Quality Assurance Commercial Operations where required.
- Track closure of quality actions linked to distribution activities.
- Ensure change controls impacting the Wholesale Distribution Authorization scope are properly assessed.
- Support preparation of documentation for Good Distribution Practice inspections.
- Coordinate responses to audit questions in collaboration with the Responsible Person and corporate Quality Assurance.
- Maintain an inspection-readiness folder and document repository.
- Support execution of internal audits where applicable.
- Coordinate information flow related to product distribution activities performed outside the Netherlands.
- Ensure traceability of product flow and availability of Good Distribution Practice-compliant documentation.
- Support verification that outsourced logistics providers operate under Good Distribution Practice requirements.
- Support development and monitoring of key performance indicators for Commercial Quality and Wholesale Distribution Authorization compliance.
- Maintain oversight of Wholesale Distribution Authorization-related key performance indicators and compliance status.
- Provide periodic updates to internal stakeholders in Quality Assurance, Supply Chain, Regulatory, and Finance.
- Highlight risks, gaps, or delays impacting compliance or licensing obligations.
- Ensure full adherence to GxP principles and internal quality standards.
- Maintain compliance with applicable regulatory requirements.
- Adhere to the company’s Health and Safety at Work and Environmental and Safety Management System policies.
- Report suspected adverse events involving medicinal products or medical devices and other safety information in line with internal regulations.
- Comply with the company’s internal policies, Code of Ethics, and related rules.
- Adhere to the environmental, social, and governance principles in the Sustainability Strategy.
Zentiva makes branded generic medicines in Europe. Its products are off-patent drugs sold under Zentiva brands with the same active ingredients and safety as the originals, usually at lower cost. The company distinguishes itself through a long history and growth by acquisitions to expand across Europe, especially after becoming independent under private equity. Its goal is to be a leading European branded generics platform by widening its product lineup and geographic reach.
Company Size
1,001-5,000
Company Stage
Acquired
Total Funding
N/A
Headquarters
Prague, Czechia
Founded
2003
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Simplify's Take
What believers are saying
- March 2026 sustainability reporting reaffirmed four plants and broad external manufacturing partners.
- GTCR's April 2026 close funds new products, portfolio breadth, and geographic expansion.
- Zentiva's 5,000-plus employees and 2025 scale support negotiating leverage with wholesalers.
What critics are saying
- August 20, 2026 recall of Fingolimod batch 4L01372H exposed contamination controls.
- A single metal-particle incident invites regulator scrutiny and pharmacy trust loss.
- Repeated recalls threaten licenses, undermine GTCR's exit, and force a distressed sale.
What makes Zentiva unique
- April 2026: GTCR bought Zentiva, backing a pure-play European off-patent platform.
- Zentiva operates four manufacturing sites across Prague, Bucharest, and Ankleshwar.
- It sells affordable medicines to over 100 million people in 40-plus countries.
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Benefits
Health Insurance
Life Insurance
Paid Vacation
Paid Sick Leave
Meal Benefits
Relocation Assistance
Flexible Work Hours
Performance Bonus
Training Programs
Professional Development Budget
Company Social Events
Growth & Insights and Company News
6 month growth
↑ 0%1 year growth
↑ 0%2 year growth
↑ 7%Class 2 Medicines Recall: Zentiva Pharma UK Limited, Fingolimod Zentiva 0.5 mg Capsules, EL(26)A/37. Zentiva UK Pharma Limited are recalling one batch of Fingolimod Zentiva 0.5 mg Capsules (BN 4L01372H) as a precautionary measure due to a potential risk of contamination with metal particles DMRC reference number. DMRC - 39754868 Marketing authorisation holder. Zentiva Pharma UK Limited Medicine details. Fingolimod Zentiva 0.5 mg Capsules. PL: 17780/0858 Active Ingredient: Fingolimod SNOMED code: 40459211000001106 GTIN: 8594739260931 Affected lot batch numbers. | Batch No. Expiry Date | Pack Size | First Distributed | | 4L01372H | 11/2027 | 28 | 28 January 2025 | Background. Zentiva UK Pharma Limited are recalling one batch of Fingolimod Zentiva 0.5 mg Capsules (BN 4L01372H) as a precautionary measure due to a potential risk of contamination with metal particles. The particles, if present, are known to be small and pose a low risk to the safety or efficacy of the tablets. No reports have been received to date, the particles were identified during shelf-life testing. Advice for healthcare professionals: Stop supplying the affected batch. Quarantine all remaining stock and return it to your supplier using your supplier's approved process. Advice for patients: If patients have the affected batch they should contact their pharmacy in the first instance. Do not stop taking your medication without speaking to your healthcare professional first. The particles, if present, are known to be small and pose a low risk to the safety of the product. Patients with this batch are not considered at risk and no reports of harm have been reported for this batch of capsules. Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme. Additional information: For all medical information enquiries and information on this product, please email [email protected], or telephone 0800 090 2408. Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information. Yours faithfully Defective Medicines Report Centre 10 South Colonnade Canary Wharf Telephone +44 (0)20 3080 6574
Demonstrating accountability: Zentiva receives prestigious ESG Transparency Award 2025. PRAGUE, Nov. 28, 2025 /PRNewswire/ - Zentiva, a leading European generics pharmaceutical company, has received the esteemed ESG Transparency Award 2025 by the EUPD Group. This award recognises companies that excel in clarity, structure and transparency in their Environmental, Social and Governance (ESG) reporting. The awards were presented at the ESG Summit 2025, as part of the European Sustainability Week 2025, hosted by the EUPD Group. The recognition is a testament to the efforts of industry leaders who have embedded sustainability in their business strategy and communicate it transparently according to relevant standards. Zentiva received recognition at the Excellence Level of the ESG Transparency Award 2025 for its high degree of clarity, accessibility and transparency in sustainability reporting. The Excellence Level distinction places Zentiva among the top organisations in Europe in terms of transparent reporting of its ESG disclosures. The company excelled in the presentation of a well-structured and strategically grounded sustainability approach that incorporates current European requirements into governance and reporting processes. Furthermore, the disclosure of climate related information, including the use of renewable electricity at European production sites and its integration into a broader long term climate strategy reached a high level of transparency. In addition, Zentiva offered a full calculation of the indirect carbon footprint with externally reviewed methodology to strengthen data integrity and clearly explained its governance structures, highlighting the role of the Audit Committee in approving sustainability related plans. These results underline the determination of Zentiva to strive to drive positive change for society and the environment. Steffen Klink, COO of the EUPD Group commented: "We proudly congratulate Zentiva on its exceptional commitment to transparent ESG communication, clearly demonstrating accountability by publicly detailing material impacts, risks, and opportunities across key environmental, social, and governance areas. This dedication to holistic performance, including ambitious decarbonization targets and robust global policies on ethical conduct and responsible sourcing, sets a definitive benchmark for industry excellence." Ines Windisch, Head of Corporate Affairs & Sustainability at Zentiva, commented: "We are truly proud to receive this award for our sustainability reporting. It acknowledges a journey that is far more than just compliance - it is about learning, testing, piloting, and acting with courage and transparency. At Zentiva we understand small steps can create a big impact, and we must act today for a sustainable tomorrow. Sustainability is not just a responsibility; it is an opportunity for people and partners to create a lasting positive impact for future generations. This award is a milestone that inspires us to keep moving forward." About Zentiva Zentiva provides health and wellbeing for all generations, with focus on developing, producing, and delivering high-quality, affordable medicines to more than 100 million people in over 30 countries across Europe and beyond. Zentiva has four wholly-owned manufacturing sites and a broad network of external manufacturing partners to ensure supply security. Zentiva employs more than 5,000 unique talents, bonded together by a commitment to the people who depend on its medicines every day. Visit Healthcare at www.zentiva.com About the ESG Transparency Award The ESG TRANSPARENCY AWARD honours European organisations that have already anchored forward-looking sustainability concepts in their company and communicate these transparently in the form of a sustainability report. These pioneers serve as role models because they change the world and prove that profitability and sustainability are not opposites, but successful strategies for a future worth living. The EUPD Group has developed the ESG Transparency Evaluation Standard to objectively assess transparency, accountability and structural quality of ESG reporting. It draws on the most relevant European and international guidelines of sustainability reporting and serves as the methodical basis of the ESG Transparency Award. www.esg-transparency-award.de/en/ SOURCE Zentiva
India's Economic Times reported last month that Aurobindo Pharma, one of India's largest generics manufacturers, had been leading the race to acquire Zentiva with an offer reportedly valued at up to $5.5 billion.
American investment firm GTCR is acquiring Czech drug manufacturer Zentiva from Advent International for €4.1 billion, including debts, as reported by the Financial Times. This sale marks a significant increase from the €1.9 billion Advent paid in 2018. The transaction, resulting from a bidding process, highlights growing investor interest in stable pharmaceutical companies in the region. The deal is expected to be officially announced soon.
Aurobindo Pharma is set to acquire Prague-based Zentiva for $5-5.5 billion, marking the largest-ever acquisition by an Indian pharma company. Competing with US firm GTCR, Aurobindo has secured a $4.75 billion credit line from MUFG, with the remaining $800 million from internal funds. This acquisition will enhance Aurobindo's European presence, especially in Eastern Europe. Zentiva's 2024 revenues are projected at €1.7 billion with an EBITDA of €400 million.