Officer - Validation in Quality Assurance

7 days ago

Mumbai, India Bharat Serums And Vaccines Full time

**Responsibilities**:
1. Responsible for planning, organizing and execution of process validation, cleaning validation and hold time study across all production lines.

2. Co-ordination with production, quality control and QA for fina-ion of sampling plan and verify effectiveness of sampling during process validation, cleaning validation and hold time study.

3. To prepare protocol and report for aseptic process simulation media fill for aseptic filling process.

4. To prepare protocol and report for manual visual inspection process and automatic visual inspection process.

5. Co-ordination with production and packing for preparation of defect kit for manual inspection validation.

6. To execute miscellaneous study protocol based on inspection / cGMP requirement

**Accountabilities and Responsibilities**:
1. Responsible for validation and qualification of process, cleaning and hold time study.

2. Support to regulatory inspections.

3. Support coordination and execution of cross-functional review along with the Function/ Department heads.

**Competencies**

1. Good Communication skills

2. Ability to deal with ambiguity

3. People, Teamwork, and High cross-cultural awareness. A team player able to work with others and without direct supervisic hands-on, ability to work in fast paced environment.

4. Drive to create an innovative, sustainable, productive and connected future

5. Curiosity to ask probing questions and make discoveries. Drive to find the right answer

6. Commitment to excellence, ensuring objectives are met and delivered on-time
- Role:
Quality Assurance - Other
- Salary:
Not Disclosed by Recruiter
- Industry:
Pharmaceutical & Life Sciences
- Department:
Quality Assurance
- Role Category:
Quality Assurance - Other
- Employment Type:
Full Time, Permanent
- Key Skills

Cleaning Validation

process validation

assurance

parental formulation

biopharmaceutical products

Aseptic formulation

Visual inspection

Skills highlighted with ‘‘ are preferred keyskills
- Education
- UG:
B.Pharma in Pharmacy
- PG:
M.Pharma in Pharmacy

Company Profile
- Bharat Serums and Vaccines
- About BSV: At Bharat Serums and Vaccines, we work in close partnership with our customers and the stakeholders to make a sustainable use of science to advance industries As part of Corporate Functions, you will help empower people, enable decision making and agility that will strengthen BSV's ability to reach healthcare answers.

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