Batch Record Reviewer at Sinclair

Almere, Flevoland, Netherlands -

Full Time

Start Date

Immediate

Expiry Date

26 May, 26

Salary

0.0

Posted On

25 Feb, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Batch Record Review, Documentation Review, Completeness Checking, Accuracy Checking, GDP Compliance, Deviation Recording, ERP System Maintenance, Data Review, Non-conformity Reporting, Administration, Communication, Excel, Word

Industry

Pharmaceutical Manufacturing

Description

Sinclair is Hiring! Join Our Team as a Batch Record Reviewer🚀 We are currently recruiting for Batch Record Reviewer at our Almere office in the Netherlands. The Batch Record Reviewer performs reviews on batch documentation completed by the Operations department. The Batch Record Reviewer (accurately reviews all completed and drafted batch documentation received from the Operations department). With the team the Batch Record Reviewer initiates actions to improve the overall quality, efficiency, and effectiveness of the batch record review process and batch record flow within the Document Control Team. Location: De Strubbenweg 17, 1327 GB, Almere About Sinclair Founded in 1971, Sinclair is a global medical aesthetics organisation, that delivers an extensive product range. With an in-house commercial infrastructure, including manufacturing and a network of distributors in leading global markets, our products are sold in 55 countries worldwide. This is a great time to join Sinclair as we continue to increase our product range and expand into new markets and territories. Sinclair Values: ✅ Act with Integrity Consistently doing the right thing even when it’s the hard choice; 100% Compliance with all rules, standard operating procedures and guidelines ✅ Results-Driven Make a business impact in all you do, whether sales, efficiency, operational excellence; it should make a meaningful impact ✅ Innovation-Centered Redefining Aesthetics, we must be pioneering in how we do business; this can be in products, in service models, or strategy ✅ One Company, One Goal Working towards unified mission, we are all Sinclair and be seen by customers as one company in every way ✅ Own It! Be Accountable for your decisions, actions and consequences; Be Reliable to your customers and colleagues What You'll Be Doing: Performs review of batch records (intermediates and final product (including intermediate products such as pouched syringes) Receives, reviews and checks batch documentation, checking for completeness, accuracy, GDP compliance as well as recording any batch deviations. As the work is not captured in detailed instructions, the Batch Record Reviewer applies general verification and knows the critical elements that are important for successful completion. Keep the total operational overview up to date (Maintain the Operations excel overview & ERP System) Releases batches upon successful review by updating the ERP system Review, print out and sign off Zirbus cycle data to be included in the batch documentation after review. Update the weekly data received from Zirbus and Autoclave for all cycles Reports any non-conformity to the relevant colleague in Quality and/or Operations · Provides back up and support to the Document Control Team. Your skills and experience Essential: Completed MBO administration English B2 Desirable: Experience with medical devices/GMP (1-2 years) · Fluent in Dutch (speaking and writing). Previous experience in a manufacturing organisation. Dutch B2 What We're Looking For: Good administration skills Good communicative skills Basic/intermediate skills of Excel/Word Able to achieve deadlines General competencies: Team player Can work under pressure Positive work attitude Perks & Benefits: 💰 Competitive Salary 🏡 Hybrid/Remote Work Options (if applicable) 📈 Career Growth & Learning Opportunities 🏥 Health & Wellness Benefits 🎉 Fun Team Events & Supportive Culture 🔹13th month bonus 🔹25 vacation days 🔹8% holiday pay 🔹Travel allowance based on €0,21 per kilometre 🔹Retirement savings plan We have a real focus on developing our people, and by fostering an entrepreneurial culture, we encourage flexibility, accountability and autonomy. The company is full of opportunity for those who wish to grasp it. Our people thrive on engagement, development and a varied workload. You will often be included in projects that require you to collaborate cross-functionally. This is an exciting opportunity to join a successful company, with big ambitions for the future. If this sounds like you and you meet the requirements, please apply, we would love to hear from you. Please note if we receive a high volume of applications, we may close the role before the closing date noted. By making this application you give consent for personal information to be used in automated decision-making processes relating to key job requirements which are stated in this ad. Sinclair does not accept speculative or unsolicited CVs from Recruitment Agencies. Any unsolicited CVs received will be treated as property of Sinclair and Terms & Conditions associated with the use of such CVs will be considered null and void.

Responsibilities

The Batch Record Reviewer performs detailed reviews of completed and drafted batch documentation from the Operations department, checking for completeness, accuracy, and GDP compliance, and recording any deviations. They are also responsible for updating operational overviews, releasing batches in the ERP system upon successful review, and reporting non-conformities.