Quality Assurance Executive

QA Executive – Quality Assurance

Experience: 3–4 Years

Department: Quality Assurance

Industry: Pharmaceutical Manufacturing

Qualification: B.Pharm / M.Pharm or equivalent relevant pharmaceutical qualification

Job Profile

We are looking for a QA Executive with 3–4 years of experience in a pharmaceutical manufacturing unit, having strong documentation skills and good computer proficiency.

The candidate will work under the guidance of the QA Head and will primarily be responsible for preparation, review and maintenance of Quality Assurance and manufacturing documentation.

Key Responsibilities

- Preparation and revision of Standard Operating Procedures (SOPs).

- Preparation of Standard Testing Specifications (STS) and Standard Testing Procedures (STP) in coordination with QC/QA.

- Preparation and revision of Master Formula Records (MFR) and related manufacturing documents.

- Preparation/review of BMR/BPR and other GMP documentation.

- Maintaining controlled documents, formats, records and document registers.

- Assisting QA Head in implementation and maintenance of the Quality Management System (QMS).

- Assisting in documentation related to deviations, change controls, CAPA and investigations.

- Coordination with Production, QC and other departments for preparation and updating of documents.

- Ensuring documents are prepared and maintained in accordance with GMP and applicable regulatory requirements.

- Supporting preparation of documents for regulatory/customer audits and inspections.

- Any other QA documentation and compliance work assigned by the QA Head.

Required Skills

- 3–4 years of relevant QA experience in a pharmaceutical manufacturing company.

- Good knowledge of GMP documentation and pharmaceutical Quality Assurance systems.

- Practical experience in drafting SOP, STS, STP and MFR.

- Excellent written English with the ability to independently draft professional technical documents.

- Must be computer friendly with good working knowledge of MS Word, Excel, PDF/document handling, email and internet applications.

- Good formatting, typing and document-management skills.

- Attention to detail and ability to maintain accurate records.

- Ability to work independently as well as under the guidance of the QA Head.

Preferred Candidate

A candidate who is strong in documentation, fluent in English and comfortable working extensively on computers will be preferred. Practical QA experience and drafting ability will be given significant importance during selection.