QA Validation - Executive

Unichem Laboratories; Ghaziabad District; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Unichem Laboratories Ltd. is seeking a qualified professional to lead qualification and validation activities within a pharmaceutical environment.

Responsibilities include preparing and reviewing equipment qualification protocols, executing qualification and requalification tasks, and validating computerized systems. The role requires experience with regulatory exposure (USFDA/MHRA/EU/TGA), knowledge of QMS software, and Lean Six Sigma basics.

Qualifications

• Experience in pharmaceuticals industry, preferably oral solid formulations, with regulatory exposure (USFDA/MHRA/EU/TGA).
• Exposure to electronic systems in QMS/software.
• Basic Lean/Six Sigma knowledge.
• Excellent verbal and written communication skills.
• Bachelor/Master in Pharmacy (B.Pharm / M.Pharm).
• Analytical and problem solving abilities.
• Ability to work independently within a team.
• Initiative and proactive approach to quality improvements.

Responsibilities

• Prepare and review equipment qualification protocols and reports.
• Execute equipment qualification and requalification activities.
• Prepare, execute and review computerised system validation.
• Prepare, review and execute temperature mapping study.
• Review facility qualification documents, layouts and drawings.
• Prepare, review, execute and compile HEPA of equipment/LAF/RLAF validation.
• Prepare and review water system qualification.
• Prepare and review validation documents for HVAC, compressed air and nitrogen utilities.
• Prepare and review Validation Master Plan.

Skills

Regulatory exposure

QMS software

Lean / Six Sigma

Communication skills

B.Pharm / M.Pharm

Analytical problem solving

Independent work in team

Proactive quality improvement

Education

B.Pharm / M.Pharm

Tools

QMS software

Job description

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.