Senior QA Specialist / Release Officer

Bioglan AB is facing increased project orders and production volumes and we need to strengthen our Quality Assurance Team with a Senior QA Specialist / Release Officer in order to meet our customers needs.

Bioglan AB is a Malmö based contract manufacturer and developer of semi solid products, i.e. ointments, creams, gels etc., today primary as pharmaceuticals but medtech and specialised cosmetic products are steadily increasing.

We take great pride in the responsibility we have been given by our customers and we continuously strive to improve our processes with the ultimate goal of high efficiency and customer satisfaction.

For further information, please visit us on www.bioglan.se

Job Description
Your responsibilities will include day-to-day QA support to the Supply Chain. This will include:

attending daily Supply Chain Management meetings
coordinating investigations, root cause analysis and risk assessments of product related non conformances and deviations
approving recommended corrections and/or corrective/preventive actions (CAPA),

You will also be overall QA responsible for the manufacturing and packaging processes of a couple of specific commercial products. Primary responsibilities will include:

final Batch Record´s review
Release/Certification of final product batches as a QP delegate
Bioglan QA to Client QA communication and meetings
coordinating Change Control requests
coordinating Risk Management activities
assuring process validation status and take part in validation projects
taking part in internal and external audits and inspections

Requirements
A successful candidate should have:
documented experience equal to the requirements in LVFS 2004:7 §7 (Krav på Sakkunnig)
three to five years of work experience in a similar position
fluent in Swedish, both written and spoken
fluent in English, both written and spoken
a LEAN mindset
excellent interpersonal and communication skill
a positive and constructive attitude
strong analytical and organizational skills
ability to meet deadlines
good computer skills

We would preferably also like the candidate to have
project management experience
experience in process validation and/or cleaning validation
experience of statistical trend analysis and data handling in MS Excel or similar
ability to write efficient Standard Operating Procedures

Application
This position offers you an unique opportunity to be a part of a small team within a company ready for changes. The company's organization and the management?s dedication enables quick decisions and influence. Your experience and expertise will be valued.

The position is permanent preferable starts in January 2016. Please note that we will proceed with suitable candidates as soon as possible. We look forward to your application!

For further information please contact Head of QASC, Nicklas Helgesson: nicklas.helgesson@bioglan.se. Your email should have the reference "QASC201510" in the subject field.

Telephone calls may be arranged upon request.