Technical QA Coach

One of our clients, an international company in the pharmaceutical industry currently requires a Technical QA Supervisor

Start: ASAP
Length: 31/12/14
Location: South of Brussels

Technical QA Supervisor

FUNCTION DESCRIPTION

1) Develop, assure and maintain the Quality of the TLCM process:
- Documentation: Standard procedures (Worldwide regulatory requirements)
- Drive the Quality Plan, follow actions in place, communicate update internally
- Follow Quality Audits (Corporate and Auto-inspection)
- TLCM Quality indicators and remediation plan
- Edit a survey of Quality standards and inform TLCM on theQuality Alerts

2) Develop and maintain the TLCM training program

3) Track TLCM Risks: properly assessed, reported and monitor in SAP

4) Deploy Quality audit programs and follow up on its implementation through the Quality council

5) Responsible for the TLCM Knowledge Management process used in TLCM

KEY RESPONSIBILITIES

1) Organize and take the responsibility for Quality Assurance in GXP activities for the TLCM Department.
- Establish SOP's for quality standards in collaboration with other departments (Quality systems/GIO/) and based on Global Quality Assurance and/or corporate policies.
- Ensure that records, standard Operating Procedures and documentationhave been completed and endorsed by the staff authorized to do so.

2) Ensure inspection readiness, auditing activities and CAPA follow up:

- Prepare regulatory inspections.
- Make sure that internal audits (self-inspection) are performed.
- Assure internal audits L2.
- Make sure that the commitments are followed up and implemented.

3) Ensure implementation of GXP training program.

- Monitor and challenge Documentation activity in order to ensurecompliance with applicable standards (QMS)/Regulations, and to ensureharmonizationmay propose new operating procedures.
- Make decisions that concern a variety of matters within own area, using incomplete information if required.
- Strong influencing skills - use a persuasive approach best suited tothe audience, striving to a win-win interaction.
- Demonstrate confidence in own ability; make timely decisions in aself-assured way and justify them, if necessary.
- Explain difficult issues and situations clearly and ensure meaning isunderstood.
- Able to create informal personal networks with key contacts within own area.
- Support others efforts to develop and promote teamwork - try toalways reach consensus among team.
- Use a range of sources and methods to obtain information relevant to a particular task or activity to drive development of expertise and encourage discussions relating to the information.
- Identify new and less obvious solutions. See multiple relations and identify patterns from partial or conflicting data, analyze the relationship between several components of a problem or situation andset priorities to problem solving.
- With continuous improvement in mind, take initiatives in developing, tailoring and modifying approaches in order to tackle new issues and situations.

Experience:

- Min. 5 years' experience in the Pharmaceutical industry and preferably in QA/QC

Tags: QC, QA, GMP, technical, CAPA, Quality, Assurance