Sr .Executive/Executive, Validation

Job Responsibility:

You will be responsible for/to:

• ensure on time availability of hold time study and process validation related documents for International Dossier Submission
• perform physical testing of hold time study products and process validation batches including raw data compilation and reporting
• perform Qualification & Re-qualification of different sterile and non-sterile processes, equipment's & Area to ensure cGMP compliance
• online data entry on excel sheets and hard copy of analytical work sheets
• maintain all log-books related to sample entries, physical and chemical testing usage
• escalate from minor to critical observations related with processes to all stake holders
• prepare protocols and reports on hold time and process validation batches
• prepare and review risks on hold time studies and PV products.

Requirements:

• PharmD/MSc Chemistry preferable but not mandatory.
• 1 to 3 years of relevant experience.
• Knowledge of validation and qualification programs as per latest international guidelines.
• Expertise of process validation and hold time study related activities.
• Experience in pharmaceutical industry (PV & HTS related activities).
• Experience to handle in-process side related activities.