Sr. Officer/ Executive - QMS

Purpose: To Support Quality Assurance Activities.

Training: To Control of training records for all departments including training planner. GMP training planning, review of training matrix etc.

For Training files checking and induction for all departments.

Qualification: To support Qualification and validation activities (change control evaluation of new product, Instruments, equipment, facility renovation, utility etc.

QMS: To support deviation related to breakdown of equipment, instrument, water system, and HVAC.

Tracking of activities: Tracking of re-qualification, calibration, and validation schedule, departmental training, training matrix. To perform all activities allocated by Head Quality Assurance.

Position/Job Title: Sr. Officer/Executive

Department: Quality Assurance QMS (Training, instrument/equipment qualification, validation of utility, process validation)

Reporting To: Manager Quality Assurance

Location: Ambernath

Years of Experience: 4-7 Years

Education Qualification: B. Pharma/M. Pharma in any specialization

Dosage Form: Solid Oral / Liquid, Nasal is preferred.

Job Responsibilities / Deliverables

• Responsible for Control of training records for all departments including training planner, GMP training planning, review of training matrix etc.
• Control of training records for all departments including training planner. GMP training planning, review of training matrix etc.
• To maintain the training tracker of QA department.
• To communicate, schedule and follow up on the training plan as per yearly calendar.
• Training files checking and induction for all departments.
• Good communication skill.
• Qualification document review.
• URS, FDS, FRA, DQ, IQ, OQ, and PQ.
• Risk assessment.
• GAP assessment.
• Executed document review.
• Other QMS activity:
• Ensure all QMS are closed as per SOP timeline.
• Review of calibration activity as per defined schedule frequency.
• Review of preventive maintenance activity as per defined frequency.
• Review of requalification activity as per defined frequency.
• Preparation of SOP.
• Good at tracking and follow up activities.
• Tracking of qualification activity as per timeline.
• Good co-ordination skills with another department.
• Good knowledge about current trends of Data integrity.

Qualifications & Pre-Requisites

• Must have skills:
• B. Pharma or M. Pharmacy in Quality Assurance is preferred.
• Good communication skill which results to co-ordination with functions like QC, Manufacturing, Engineering, Warehouse, Nasal, TT, PPIC, etc.
• Must have knowledge on handling Qualification and validation.
• Exposure to various regulatory bodies like US FDA, MHRA, TGA.
• Exposure to specific dosage forms like OSD, Nasal.
• Team co-ordination and work distribution.

Additional notes

• Role is expected to work in all shifts.