Batch Record Reviewer
Sinclair is Hiring! Join Our Team as a Batch Record Reviewer๐
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:
โ
Act with Integrity Consistently doing the right thing even when itโs the hard choice; 100% Compliance with all rules, standard operating procedures and guidelines
โ
Results-Driven Make a business impact in all you do, whether sales, efficiency, operational excellence; it should make a meaningful impact
โ
Innovation-Centered Redefining Aesthetics, we must be pioneering in how we do business; this can be in products, in service models, or strategy
โ
One Company, One Goal Working towards unified mission, we are all Sinclair and be seen by customers as one company in every way
โ 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 ยท 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) ยท 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:
๐ฐ Competitive Salary
๐ก Hybrid/Remote Work Options (if applicable)
๐ Career Growth & Learning Opportunities
๐ฅ Health & Wellness Benefits
๐ Fun Team Events & Supportive Culture
๐น13th month bonus
๐น25 vacation days
๐น8% holiday pay
๐นTravel allowance based on โฌ0,21 per kilometre
๐นRetirement 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.
- Division
- Operations
- Department
- QUALITY
- Locations
- Sinclair, The Netherlands