Assistant Section Manager-Otsuka Pharma, Ahmedabad

Role & responsibilities

1. The candidate should be capable to handle validation and qualification related activities independently.

2. Responsible for preparation, execution and review of Qualification and validation protocols and reports.

3. Responsible for performing and allocation of validation and Qualification, media fill related activities in microbiology lab.

4. Responsible to execute the microbiologist analyst Qualification.

5. Responsible for environment monitoring and personal monitoring activities.

6. Responsible to perform sterility test method validation, Bacterial endotoxin test method validation, Microbial limit test method validation and disinfectant validation.

7. Responsible for analysis of sample and review of validation, process validation, cleaning method validation, media fill, holding time and miscellaneous validation activities as per requirement's.

8. Responsible for initiating and participating in Quality management systems such as Change conytol, deviations, incidents, investigation and CAPA in microbiology lab.

9. Responsible for maintaining microbiology lab always ready for any regulatory audit's.

10. Responsible for arrange training as and when requird to microbiology team.

11. Responsible for preparation and review and implementing of SOP time to time.

12. To follow the company HR, c GMP, GDP, data integrity policy, rules and regulations as per regulatory requirements.

Preferred candidate profile

• Ready to work in Rotational shifts.
• Excellent understanding about working area.
• Initiator and Learner.
• Decision making ability.
• Team player and if required, can provide training to other team members.
• Good communication.
• Candidates from Parental or Injectable would be given preference.

Interested candidate can also share their resume on email id- Anee.Silas@otsukapharma.in