QA Validation - Sr. Officer and Executive

Responsibilities

• Prepare & review equipment qualification Protocols & reports.
• Execute the Equipment qualification / requalification activity.
• Prepare, execute & review computerized system validation.
• Prepare, review & execute temperature mapping study.
• Can review of facility qualification document, layouts &drawings
• Prepare, review, execute & compilation of HEPA of equipment/LAF/RLAF validation.
• Prepare, Review & execute of water system qualification.
• Prepare & review of utility validation document (HVAC, compressed air & Nitrogen).
• Prepare & review of validation master plan.

DESIRED SKILLS

1) Candidate should have working experience in Pharmaceutical Industry preferably Oral Solid Formulations and have regulatory exposure of USFDA/ MHRA/EU/TGA etc.

2) Exposure of electronic system in QMS/Software.

3) Basic Lean/ Six sigma knowledge.

4) Candidate should have excellent verbal & written communication Skill.

5) Qualification required B. Pharm / M. Pharma

6) Candidate should have analytical and problem solving skill.

7) Can work independently in team.

8) Can able to take initiatives and proactively seek quality solutions through emphasis on continuous improvement.