CAREERS

POSITION PURPOSE
A brief summary of the purpose this position must fulfill.

The Supplier Quality Management Executive will be responsible for ensuring that the vendor management program is effectively evaluating and documenting vendor performance.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
To perform this job successfully, an individual must satisfactorily perform each essential duty. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

1. Investigation of product complaints, OOS and non-conformances of Third Party Manufacturers (TPMs), Vendors etc.;
2. Ensure CAPA’s closed in a timely manner;
3. Support the Vendor Management System;
4. New Vendor/CMO assessment and approval;
5. Prepare Change Control/Deviation for Vendors and TPMs for approval;
6. Review Annual Product Reports and Product Quality Reviews from TPMs;
7. Prepare TPM finished product documentation for disposition;
8. Review batch manufacturing and packaging records of TPM products;
9. Review validation and stability protocols and reports;
10. Assist in the preparation of Technical Agreements as required;
11. Participate in Internal Auditing Programme;
12. Preparation and review of SOPs as required;
13. Perform other duties as assigned.

QUALIFICATIONS

The qualifications listed below are representative of the minimum knowledge, skill, and/or ability required.

KNOWLEDGE
Knowledge of Pharmaceutical QMS Systems;
Knowledge of Quality Risk Management Systems;
Knowledge of cGMPS i.e., USFDA, 2003/94/EC, MHRA and WHO;
Knowledge and experience in the use of Data Sharing Software Packages an advantage.

SKILLS AND ABILITIES
Excellent verbal and written communication skills. Computer skills i.e., Microsoft Office, Windows etc.

SUPERVISION
Position functions with supervision.

EDUCATION/EXPERIENCE
Minimum of a Bachelor's degree (or equivalent) in a life science and 5 years of experience in a Quality management role within the pharmaceutical sector with previous experience in supplier quality management desirable.

However, a combination of experience and/or education will be taken into consideration.

LICENSES/CERTIFICATIONS
None required.

LANGUAGE SKILLS
Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with managers or directors and communicate ambiguous concepts. Ability to present to groups across the organization.

MATHEMATICAL SKILLS
Ability to do all kinds of mathematical calculations and statistical analysis.

REASONING ABILITY
Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis. Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems.

PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.

Typically sitting at a desk or table. Intermittently sitting, standing, walking or stooping. Periodic travel is required.

WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.

Normal office situation.


TO APPLY

Please forward cover letter and CV to careers@bionichepharma.com