Quality Assurance Officer

Company : Pharmaceutical & Medical Device Trading Company (MNC)

Position : QA Officer

Job Location : Ahmedabad

Job Role : To assess and pre-qualify manufacturers and products including pharmaceutical products, medical devices as well as other activities relating to co-ordination of documents, execution of segment projects, & QA related tasks.

MANUFACTURE ASSESSMENT

1. Perform desktop evaluations of plants as applicable.

2. Verification of ISO and other certificates for its authenticity with certificate issuing body.

3. Visit of manufacturer for document/DESKTOP audit OR for cause audit, on need base

PRODUCT ASSESSMENT

4. Collect and assess documents needed for product approval included but not limited to product questionnaires, product specifications, release criteria, stability studies.

5. Review and approval of product documentation in share point.

6. Verification of CE and other certificates for its authenticity with certificate issuing body.

7. Undertake the necessary discussions and explanations with the manufacturer with reference to product query.

8. Prepare assessment for product approval and product datasheet.

9. Assist in review of Pharmaceuticals & medical device with reference to layout approval and review.

10. Evaluation of temperature files from shipments reaching customers

DEVELOPMENT AND OTHER SUPPORTING ACTIVITIES

11. Creation of item codes and plant codes in AX.

12. Handling of QD mailbox, ECM request and assisting with QD support function.

13. Assist in the implementation of quality management system and compliance to global and site-specific procedures

14. Support corporate QA in defining, revising and implementing QMS and Standard operating procedures.

15. Evaluation of temperature files of warehouse and concluding with proper justification or risk assessment

16. Assist in implementing various projects where quality function is involved and required.

17. Act as a segment specific solution for quality related

Desired Profile

• Master/Bachelor degree/diploma in Pharmacy or science stream.
• Work experience: 4-6 years experience from a QA/QC/Production/Regulatory department of a manufacturer finished dosage forms preferably for the international markets.
• On hands experience with Quality systems and GMP related issues including SOPs, Stability, QA/QC and Manufacturing processes.

Competences Required :

• Should have basic understanding of overall quality management system (QMS) and shall be able handle various documents of QMS
• Updated on WHO tech. report series 937, EU GMP, ISO 9001, ISO 13485 and ICH guidelines and able to explain and justify audit findings in a simple understandable manner.
• Excellent communication skills, should Understand and be oriented towards ERP system /Share point and use it efficiently within own area.
• Well structured, detail oriented, efficient with ability to follow up and communicate results. Should be able to review documents such as Certificate of Analysis, Site Master Files, stability studies, manufacturing processes and product specifications relating to a product.
• Should be able to enter a dialogue with external parties such as manufacturer/laboratories to facilitate improvement of the product/GMP level.
• Ability to use current job-related computer software and databases with proficiency in Microsoft Office package, in particular Word, Excel and PowerPoint, is required.
• Should follow core values and be a team player Personality must be self-confident and neutral knowing the right code of conduct.

Contact

Rina Arun