Production Pharmacist

About the role

Sehat Medical Devices Pvt. Ltd. is looking for an experienced Production Pharmacist to lead manufacturing compliance, regulatory affairs and product quality at its medical disposables plant in Lahore. The role bridges production, quality, engineering and regulatory teams to ensure all activities meet ISO 13485, GMP and DRAP requirements.

Key responsibilities

• Supervise and review manufacturing, assembly, packaging and sterilisation processes.
• Ensure adherence to SOPs, batch records, specifications and regulatory standards.
• Review and release documentation for batch manufacturing, packaging and sterilisation.
• Coordinate line clearance, in‑process controls, traceability and batch documentation.
• Investigate deviations, non‑conformities, complaints and out‑of‑specification results.
• Participate in CAPA, change control, validation, risk management and continuous improvement initiatives.
• Manage medical device registrations, establishment licensing, renewals, variations and regulatory submissions to DRAP.
• Maintain regulatory records and support DRAP inspections, ISO 13485 audits and other certification audits.
• Verify that devices are manufactured, inspected, sterilised and released according to approved standards before endorsing warranties.
• Issue and maintain warranty documentation for sold devices.
• Oversee storage, handling, issuance and traceability of raw materials, components, WIP and finished products.
• Train plant personnel on GMP, ISO 13485, regulatory compliance and good documentation practices.

Required profile

• Pharm‑D from a recognised institution with a valid registration from the relevant Pharmacy Council.
• Minimum five years of experience in pharmaceutical or medical‑device manufacturing.
• Eligibility to act as technical staff under Rule 6(c) of the Medical Devices Rules.
• Hands‑on experience in regulatory affairs, including device registrations, licensing, renewals and DRAP coordination.
• Strong knowledge of DRAP Act, Medical Devices Rules, ISO 13485, GMP and related regulatory requirements.

Required skills

• ISO 13485 compliance
• Good Manufacturing Practice (GMP)
• CAPA management
• Change control
• Validation and risk management
• Batch documentation and product release
• Regulatory affairs for medical devices (DRAP)