Key Responsibilities:
Lead validation working parties for organizing validation activities for new systems, IPC, analytical equipment, spread sheets, process or cleaning validation studies.
Ensure validation activities and documentation are complying with mandated QMS requirements under supervision of validation section head/ validation lead.
Preparation of manufacturing process/packaging qualification protocols and reports with defining the appropriate control strategy, sampling plan and reflection of the outcome in respective manufacturing records.
Update the SOPs and ensure that the MBRs are updated to reflect the recommendation outcomes of the validation and holding activities.
Prepare DR, IQ/OQ, PQ protocols and reports for new systems, IPC, and analytical equipment.
Support the implementation of company EHS rules.
Prepare decommissioning protocols and conduct related activities to ensure proper spreadsheet, IPC, or Analytical lab equipment decommissioning and summarize the activity in a report.
Conduct bulk hold time studies and ensure batch manufacturing and packaging records are updated accordingly.
Support GPS implementation for managing validation different activities.
Knowledge/ Education / Previous Experience Required:
University Bachelor Pharmacy degree
0 to 3 years of working experience
Previous working experience in Pharma industry is an advantage
Good command of the English language
Good Computer Skills
Excellent communication and interpersonal skills
Actively seek to improve processes, controls and expand effectiveness and efficiency.
Self-motivated planner with good stakeholder and people management.
Ability to work independently and as part of a team.
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