Sr. Associate Compliance

Location Netherlands
Discipline: Pharmaceutical
Job type: Temporary/Freelance
Contact name: Ernest Banor

Contact email: e.banor@panda-int.com
Job ref: 13833
Published: about 1 month ago

 

Sr.  Associate Compliance (Global Distribution)

A Renowned Pharma company in Breda is looking for a Sr. Associate Compliance who is up for a new challenge, to Contribute continuously to improve the level of GDP compliance in Global Distribution Supply Chain.

Responsibilities

• Own and manage temperature assessment records (CTETS)

• Own and manage minor and major deviation records and lead root cause analysis sessions

• Own and manage CAPA and CAPA EV records, ensuring that they are implemented as intended.

• Manage missing product notifications, including leading Event Review Team meetings if applicable.

• Support audits and inspections involving Global Distribution.

• Support activities for product recall or annual mock recall exercises.

• Maintain data accuracy and perform data analysis for Management reviews of the quality system on a periodic basis.

• Incidental travel might be required.

 

Qualifications

Minimum Requirements

• Bachelor’s degree or equivalent in Life Sciences + 2 years’ experience in GMP / GDP compliance

• In the absence of a Life Sciences degree, 4+ years’ experience in GMP / GDP compliance

• Sound knowledge of Quality Assurance principles, Good Manufacturing Practice and Good Distribution Practice.

• Fluency in English, Dutch-preferable

• Strong word processing, database and spreadsheet application skills and experience in Quality Management Software systems (e.g., Track Wise, EDMQ, etc)

 

Preferred Requirements

• Experience in audit / inspection support

• Technical writing skills

 

Competencies

• Effective communication skills at multiple levels, areas and countries

• Ability to apply risk-based approach, making decisions and escalating issues appropriately

• Analytical and evidence-based approach to problems.

• Ability to see the connection between issues, to identify common factors and bring the correct stakeholders together.

• Pro-active in proposing solutions and driving tasks to completion

• Works autonomously, respecting deadlines

• Works with a high degree of discipline and attention to detail

 

Location: Breda

Start date: ASAP

Duration: 1 year (possibility of extension)

 

Interested?

Please apply with CV. For further information, call Ernest Banor on +31 20 20 44 502 or by email at e.banor@panda-int.com