Job description
Posted Date: Aug 9 2020
Job Purpose
Represent validation activities with validation working parties and generate required validation documentation as well as executing/ witnessing validation activities.
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's 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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