Job Title: Officer - Parenteral
Purpose of Job
To supervise all activities in oncology parenteral department, Visual inspection area, external vial
washing and freeze dryer technical area activities.
Skill Required
To supervise all activities in oncology parenteral department, Visual inspection area, external vial
washing and freeze dryer technical area activities.
Roles and Responsibilites
To ensure cGMP compliance in the department.
2. To ensure area, equipment and line clearance and cleaning of equipment before startup of the
operation.
3. To ensure that after completion of operation line closure activity should be performed in
accordance with SOPs.
4. To ensure that deviation, change control, CAPA is generated as and when required.
5. To maintain the area cleanliness and arrangement before and after completion of activities.
6. To provide technical support relating to equipment utilized in the area by repairing, maintaining
and modifying production equipment utilizing technical expertise, technical manuals, precision tools
and test equipment.
7. To provide the versatility training and development of the team members.
8. To prepare the SOPs related to area and contribute to revision of SOPs.
9. To prepare MPCR and to ensure the production operations are followed as per the MPCR.
10. Responsible for completion of all documentation in a timely manner and to ensure that all the
Equipment log, records of housekeeping,formats and MPCRs are online.
11. Execution of qualification activities as per qualification protocol.
12. To ensure that production is going as per predefined schedule.
13. To co ordinate with engineering department for normal functioning of the machine in the
departments. Also adhere to the preventive maintenance and calibration schedules.
14. Any other job assigned by the superiors.
15. In absence of said employee his/her job responsibility shall be taken care by another
employee working along / under /above him/her and shall be mention in job responsibility.
16. To ensure the compliance of EHS norms in Parenteral area.
17. To follow ‘Good Documentation Practices and Data Integrity’ requirements during any GxP
Operation and recording at site.
18. To take responsibility that application of Data Integrity requirements and potential
consequences for not following it are understood and followed.
19. To review in the perspective of compliance to Data Integrity requirements while reviewing any
GxP data (Records, Reports) specific to Job description.
20. To ensure that, In case of any event of potential data breach, it shall be handled through SOP
on ‘Handling of Potential Data Integrity Observation’.
21. To supervise all activities in oncology parenteral department, Visual inspection area, external
vial washing and freeze dryer technical area activities.
Qualification Required
B.Pharmacy with reputed co.
Relevant skills / Industry experience
Should have 4 - 5 years of experience in sterile mfg.
Relevant professional / Educational background
Any other requirements (If any)
Compensation / Reward
SEZ, Ahmedabad, GJ, IN, 382213