Quality Assurance Lead
vor 4 Wochen
Quality Assurance Lead & Compliance Officer
Fraser Dove International is collaborating exclusively with a prominent pharmaceutical company that specializes in generics. With a global presence, this organization is dedicated to enhancing the quality of life by minimizing healthcare expenses while providing high-caliber medications.
Our client is in search of a Quality Assurance Lead to oversee and ensure adherence to quality assurance protocols and regulatory standards.
Your Key Responsibilities:
As the Quality Assurance Lead, your performance will be evaluated based on the following key responsibilities:
1) Serving as the Responsible Person (RP) for the organization to maintain Good Distribution Practice (GDP) standards within the Austrian division and acting as a support resource for the German division.
2) Ensuring compliance with EU Good Distribution Practices, Quality Assurance benchmarks, and pertinent GxP regulations. Acting as the main point of contact between regional Quality/Regulatory Affairs teams and local operations to promote effective communication.
3) Implementing Quality Management Systems and relevant Standard Operating Procedures (SOPs) in the Austrian office to guarantee alignment with EU-GMP, EU-GDP Guidelines, and local regulations.
Key Duties:
As the Quality Assurance Lead, your duties will encompass:
- RP Dispositioning: Ensure prompt dispositioning of products for the Austrian market and manage any necessary transactions.
- Act as a backup RP for the organization in Germany.
- Oversee quarantine, recalls, on-hold items, and market returns to avert unauthorized distribution.
- Monitor the GDP performance of Austrian contract warehouses.
- Serve as the primary customer interface for complaints, complaint samples, and complaint resolution letters.
- Batch Records Review: Review batch records, including Certificates of Analysis, Certificates of Conformity, and incoming inspection reports.
- Identify and address any deviations found in temperature and humidity data recorded during transportation.
- Effectively manage batch documentation.
- Communication and Coordination: Maintain clear communication with Supply Chain, manufacturing, warehouses, packaging sites, and customers/patients to follow up and provide requested information.
- Quality System Management: Support the management, development, and optimization of the local quality system as part of the implementation for the European Quality Management System (QMS).
- Monitor and maintain local databases of various Quality Systems (e.g., change control, deviation, CAPA, complaint, training).
- Handle GxP-related tasks, including but not limited to: documentation system, deviations, change control, CAPA, customer complaints, recall management, and training system.
- Conduct self-inspections and follow-up activities; liaise with the European QA function, manufacturing sites, and third-party suppliers to secure the necessary documentation to the required level of quality.
- Prepare thoroughly for audits and inspections.
- Data Analysis and Reporting: Provide consistent data analysis and KPI reporting.
- Regulatory Compliance: Ensure timely responses to requests from local regulatory authorities according to respective national legislation and diligently monitor follow-up actions.
- Additional Support: Offer assistance to other divisions and participate in local/regional projects on an ad hoc basis, as required.
Qualifications and Skills:
To excel as the Quality Assurance Lead, you will need the following qualifications and skills:
- Educational Background: Bachelor's or Master's degree in Life Sciences, such as Chemistry, Biology, Biochemistry, or Pharmacy.
- Professional Experience: A minimum of 2 years of experience in pharmaceutical quality and distribution, with practical experience as an RP.
- Basic or intermediate understanding of EU cGMP, EU GDP, and other relevant regulatory requirements.
- Experience in documentation control and review.
- Skills & Attributes: Strong analytical thinking and problem-solving abilities.
- Ability to maintain composure under pressure.
- Effective prioritization and multitasking skills.
- Proficient in interpreting documents and asking insightful questions to quickly gather necessary supporting information.
- Resilient, pragmatic, and diligent.
- Structured and methodical thinker.
- Ability to cultivate strong business and personal relationships.
- Excellent verbal and written communication skills.
- Team-oriented mindset.
- Flexibility and adaptability.
Benefits:
These are the perks and benefits that will complement your base salary:
- Bonus
- Healthcare
- Pension
- Relocation
Join Us:
Fraser Dove International is a specialist executive search firm dedicated to the life science industry. We are passionate about connecting exceptional life science organizations with the talent they need to design, manufacture, and distribute life-changing drugs, treatments, and devices that transform and save patient lives.
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