Latest Jobs at Shalina Healthcare

Job Summary

• The Regulatory Pharmacist is responsible for ensuring that all pharmaceutical manufacturing operations comply with national and international regulatory standards.
• This includes overseeing product registration, ensuring Good Manufacturing Practice (GMP), and liaising with regulatory bodies such as NAFDAC, PCN, and PSN.

Key Responsibilities

• Develop and implement strategies to ensure regulatory compliance across all operations.
• Register pharmaceutical products with NAFDAC and ensure timely renewals.
• Ensure production and manufacturing activities comply with WHO GMP, NAFDAC, PCN, Federal Ministry of Labour, and NIS ISO 9001:2015 standards.
• Review and authorize Batch Manufacturing Records (BMRs) and other production documentation.
• Liaise with regulatory bodies including NAFDAC, PCN, PMGMAN, and relevant government ministries.
• Oversee the registration and renewal of premises licenses (including warehouses) with PCN.
• Handle market complaints in collaboration with Quality Control (QC) and Quality Assurance (QA) teams.
• Monitor and interpret changes in regulatory guidelines and ensure internal compliance.
• Guide internal teams and management on regulatory requirements and best practices.
• Ensure all professional activities are covered by adequate professional indemnity.
• Participate in advocacy and corporate responsibility programs to maintain stakeholder relationships.
• Process and obtain chemical permits and other regulatory documentation.

Qualifications and Experience

• Minimum Education: B. Pharm
• License: Must be a registered and licensed Pharmacist with PCN
• Experience: Minimum of 3-5 years in regulatory affairs and pharmaceutical production.

Skills:

• Strong knowledge of Nigerian pharmaceutical regulations
• Excellent communication and documentation skills
• Ability to manage compliance and regulatory audits
• Familiarity with GMP, CGMP, and pharmacovigilance practices.

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Job Summary

• To ensure the efficient, compliant, and safe manufacturing of pharmaceutical products by supervising production activities, monitoring adherence to cGMP and regulatory requirements, and supporting continuous process improvement

Key Responsibilities

• Supervise and coordinate day-to-day production operations in accordance with approved SOPs, cGMP, and regulatory standards.
• Ensure proper documentation of batch manufacturing records, logbooks, and related documents in compliance with GDP.
• Monitor in-process operations to ensure quality, safety, and efficiency of production.
• Conduct line clearance, equipment checks, and ensure proper cleaning and sanitization before and after production.
• Collaborate with QA, QC, Engineering, and Supply Chain to ensure smooth production flow.
• Train, guide, and monitor operators/technicians on production processes, hygiene, and safety practices.
• Identify deviations, report non-conformances, and support implementation of corrective and preventive actions (CAPA).
• Assist in validation and qualification of equipment, processes, and cleaning procedures.
• Maintain strict compliance with EHS (Environment, Health & Safety) policies and ensure safe workplace practices.
• Participate in audits (internal, external, regulatory) and ensure readiness of production area at all times.
• Contribute to continuous improvement initiatives aimed at enhancing productivity, minimizing wastage, and optimizing resources.

Key Performance Indicators (KPIs)

• Compliance with cGMP and SOPs (zero critical deviations).
• Batch rejection and rework rates.
• Production yield and efficiency.
• Timely completion of production schedules.
• Audit readiness and compliance status.
• Staff training and competency development.

Qualifications & Experience

• Bachelor of Pharmacy (B.Pharm) or Doctor of Pharmacy (Pharm.D).
• Current registration with Pharmacists Council of [Country].
• 2–5 years of experience in pharmaceutical production, preferably in [dosage forms: tablets, capsules, injectables, creams, etc.].
• Strong knowledge of cGMP, GDP, and regulatory requirements (NAFDAC, WHO, FDA, etc.).
• Proficiency in documentation and compliance with pharmaceutical manufacturing guidelines.

Skills & Competencies:

• Strong attention to detail and commitment to quality.
• Good leadership, supervisory, and team management skills.
• Excellent problem-solving and decision-making ability.
• Strong communication and interpersonal skills.
• Ability to work under pressure and meet production timelines.
• Computer literacy (MS Office, ERP systems preferred).