QMS Implementation and Support Executive

Job Title: QMS Implementation and Support Executive

Location: Gulshan-e-Iqbal, Karachi

Job Description:

• Lead end-to-end software implementation projects for QMS, LIMS, and MES platforms at client sites, ensuring delivery on agreed timelines.
• Configure software modules to reflect client-specific workflows such as batch record management, deviation handling, CAPA, OOS investigations, change control, and stability testing.
• Assist clients in mapping regulatory requirements — FDA 21 CFR Part 11, EU Annex 11, ICH Q10, ISO 9001/17025 — to system configurations and validation documentation.
• Provide Tier-1 and Tier-2 technical support; investigate and resolve client-reported issues or escalate with full context to senior staff.
• Conduct user training sessions for different client roles (QA officers, lab analysts, production supervisors), ensuring practical adoption of the software.
• Prepare and maintain client-facing documentation including SOPs, user guides, FAQs, training materials, and configuration change logs.
• Maintain ongoing client communication to track satisfaction, surface improvement opportunities, and build long-term relationships.
• Collaborate with the product and development team to translate recurring client pain points into product improvement feedback.
• Support IQ/OQ/PQ validation activities and prepare validation summary reports where required

Requirements:

• Pharm-D, M.Sc. Chemistry, M.Sc. Microbiology, B.Sc. Pharmacy, or equivalent life sciences degree.
• 1–3 years of hands-on experience in a pharmaceutical QA or QC department.
• Practical understanding of core QA workflows: batch record review, deviation and CAPA management, OOS investigations, change control, and audit preparation.
• Familiarity with GMP/GLP compliance requirements in a production or laboratory environment.
• Strong verbal and written communication in English — ability to explain technical or regulatory concepts clearly to non-technical users.
• Structured problem-solving approach: comfortable owning an issue from first report through to resolution.
• Detail-oriented with a proactive mindset — identifies and flags friction before clients need to escalate.
• Comfortable managing multiple client accounts simultaneously with shifting priorities

Job Type: Full-time

Experience:

• Pharmaceutical Quality Assurance and Quality Compliance: 1 year (Required)

Work Location: In person