Trainee Officer, IPQA

To issue, retrieve & control of Documents

To comply Good Documentation Practices.

To perform the role & responsibilities defined as per TMS software. •Escalation to Superior for major non- conformities timely.

To participate in Visual Inspector Qualification activities.

To interact with cross functional teams to achieve organisational goals.

To participate in media fill activity.

To give line clearance & in-process control at all stages of manufacturing & Packing.

To perform sampling of all kind of intermediate samples, finished product & retain samples timely.

To perform sampling of process validation and cleaning validation sample as and when required.

To fulfil the sample requirements of external parties/ regulatory submission.

To withdraw stability samples as per the requirement.

To perform Control Sample Management activities.

To perform In process testing and release.

To perform AQL at visual and packing stage.

To prepare data trending for CPV.

To perform validation activities as and when required.

To follow the work instruction given to him (via verbal communication or through other type of communication media) other than defined in Job Description.

Skill:

• In-depth knowledge of cGMP, GLP, and GAMP guidelines.
• Knowledge of ALCOA+ principles for data integrity.
• Handling of electronic batch records (EBR) and quality systems like TrackWise, SAP-QM, etc.
• Proficiency in Deviation, CAPA, Change Control, and Out of Specification (OOS) documentation.
• Understanding of aseptic area classifications
• Oversight of media fills, sterilization processes, and environmental monitoring.
• Line clearance and area clearance before batch start.
• Oversight of visual inspection for particulates and defects in injectables.

Education: B.Pharma/ M.Pharma in Pharmaceuticals Total Experience - 1- 3 Year inexperience in IPQA : Candidates who want to apply for internal jobs, must have completed atleast 1 years within existing role.