Quality Assurance Pharma Industry

2 weeks ago

Gummidipoondi Chennai Tamil Nadu, India Green signal bio Pharma private Limited Full time

**Company**: GreenSignal Bio Pharma Pvt Ltd
**Location**: Gummidipoondi, Chennai, Tamil Nadu
**Experience**: 5-8 years in QA Validation, preferably in the pharmaceutical industry, specifically in vaccine manufacturing and sterile injectables
**Educational Qualification**: MSc Microbiology/Biotechnology/B. Pharm/B.Tech with relevant industry experience

**Job Title: Executive - Quality Assurance (Validation)**

**Job Summary**:
The Executive - QA (Validation) will be responsible for overseeing the development, implementation, and maintenance of validation processes within the sterile injectable and vaccine manufacturing environment. This role ensures all validation activities comply with regulatory requirements and industry standards, contributing to product quality and operational excellence.

**Minimal Qualification Requirements**:

- MSc in Microbiology/Biotechnology, B. Pharm, or B.Tech with 5-8 years of experience in vaccine biologicals and injectables
- Strong experience in sterile injectable facilities
- In-depth knowledge of validation for clean rooms, HVAC systems, water systems, and process equipment
- Strong understanding of regulatory requirements for validation activities (e.g., FDA, EU, WHO)

**Key Responsibilities**:

- Oversee the development, review, and approval of validation protocols and reports.
- Develop and implement quality assurance (QA) strategies for validation activities.
- Ensure validation activities are conducted in compliance with regulatory requirements (e.g., FDA, EU, WHO).
- Ensure adherence to 21 CFR Part 11, EU GMP Annex 15, and other relevant regulatory guidelines.
- Provide expert guidance on regulatory requirements related to validation processes.
- Develop and deliver comprehensive training programs for QA validation staff.
- Identify areas for continuous improvement in QA validation processes and implement best practices.

**Skills and Competencies**:

- Strong knowledge of validation principles for sterile environments and pharmaceutical equipment
- Expertise in regulatory compliance, including FDA, EU GMP, and WHO guidelines
- Proficient in drafting and reviewing validation protocols and reports
- Strong analytical, problem-solving, and risk assessment skills
- Excellent communication and interpersonal skills for cross-functional collaboration
- Ability to manage multiple validation projects effectively
- Commitment to continuous improvement and quality excellence

**About GreenSignal Bio Pharma Pvt Ltd**:
GreenSignal Bio Pharma Pvt Ltd is a leading pharmaceutical company dedicated to delivering quality healthcare solutions, with a strong focus on vaccine manufacturing and biological products. Our commitment to innovation, compliance, and operational excellence drives our success.

**How to Apply**:
Contact us at**:73055 21762**

**Job Types**: Full-time, Permanent

Pay: ₹25,000.00 - ₹45,000.00 per month

**Benefits**:

- Commuter assistance
- Food provided
- Health insurance
- Provident Fund

Schedule:

- Day shift

Supplemental Pay:

- Yearly bonus

**Education**:

- Master's (preferred)

**Experience**:

- QA Validation: 3 years (preferred)

Work Location: In person

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