The Production Pharmacist is responsible for supervising and coordinating pharmaceutical manufacturing activities to ensure that products are manufactured according to approved procedures, Good Manufacturing Practices (GMP), quality standards, and Regulatory requirements.
The role involves Overseeing Production processes, ensuring accurate documentation, Monitoring Personnel and equipment, and maintaining Compliance with company Policies and applicable Regulatory standards.
The ideal candidate must have relevant pharmaceutical manufacturing experience, sound Knowledge of GMP, and the Ability to manage Production Activities efficiently while ensuring product quality, safety, and timely delivery.
Key Duties and Responsibilities
Pharmaceutical Production Operations:
Supervise daily pharmaceutical manufacturing activities, including dispensing, mixing, granulation, compression, capsule filling, coating, liquid preparation, and filling, as applicable to the company's products.
Ensure that production activities are carried out according to approved Batch Manufacturing Records (BMRs), Standard Operating Procedures (SOPs), and work instructions.
Monitor production processes to ensure compliance with approved manufacturing specifications and established quality standards.
Ensure Proper Line clearance before the commencement of Production and between product batches.
Coordinate with production supervisors and operators to achieve daily and monthly production targets.
Monitor production yields, material usage, and process losses, and investigate significant discrepancies.
Ensure that equipment and production areas are properly cleaned, maintained, and ready for use.
Good Manufacturing Practice (GMP) and Quality Assurance:
Ensure strict adherence to current Good Manufacturing Practices (cGMP) and applicable regulatory requirements.
Ensure compliance with approved manufacturing procedures, hygiene standards, gowning requirements, and contamination-control measures.
Identify and report deviations, non-conformances, and out-of-specification process results.
Participate in investigations, root-cause analysis, corrective and preventive actions (CAPA), and other quality improvement activities.
Work closely with Quality Assurance (QA) and Quality Control (QC) to Resolve production-related quality issues.
Ensure that products are manufactured under appropriate conditions to prevent cross-contamination, mix-ups, and other quality risks.
Support internal and external audits and regulatory inspections.
Production Documentation and Reporting:
Ensure accurate, complete, and timely documentation of all manufacturing activities.
Review Batch Manufacturing Records and associated production documents for completeness and compliance.
Ensure proper recording of batch numbers, raw materials, equipment details, process parameters, yields, and Personnel involved.
Ensure that all entries comply with Good Documentation Practices (GDP), including correction of errors in accordance with approved procedures.
Prepare daily, weekly, and monthly production reports.
Report production deviations, equipment breakdowns, material shortages, and other operational challenges to the Production Manager.
Maintain proper records of production activities, cleaning, equipment usage, and in-process controls.
Personnel Supervision and Training:
Supervise production operators, line leaders, and other assigned production personnel.
Allocate duties and monitor staff performance to ensure operational efficiency.
Train production personnel on GMP, SOPs, hygiene, safety, and correct equipment operation.
Ensure that personnel follow approved gowning procedures and maintain good housekeeping practices.
Promote discipline, teamwork, accountability, and continuous improvement within the production department.
Identify staff Training needs and recommend appropriate Training programmes.
Equipment and Material Management:
Ensure the proper handling, storage, dispensing, and use of raw materials and packaging materials.
Verify material identity, status labels, and required documentation before use.
Ensure that production equipment is used only when appropriately cleaned, qualified where required, and released for use.
Coordinate with Engineering and Maintenance to address equipment breakdowns and preventive maintenance requirements.
Monitor material reconciliation and investigate discrepancies in quantities issued, used, rejected, or returned.
Minimise wastage and promote efficient utilisation of materials, manpower, and equipment.
Health, Safety, and Environmental Compliance:
Ensure compliance with workplace health, safety, and environmental procedures.
Enforce the proper use of personal protective equipment (PPE).
Ensure safe handling of pharmaceutical ingredients, chemicals, and cleaning agents.
Report accidents, incidents, unsafe practices, and potential hazards promptly.
Maintain clean, organised, and Safe Production Areas in accordance with company requirements.
Key Performance Indicators (KPIs)
The Production Pharmacist's performance will be assessed using the following indicators:
Production target achievement: Percentage of planned production targets achieved.
Batch documentation accuracy: Completeness and accuracy of batch records.
GMP compliance: Number and severity of production-related GMP deviations.
Product quality: Rate of batch rejection, rework, and production-related defects.
Production yield: Achievement of approved yield targets and reduction of
Production efficiency: Reduction in downtime and avoidable process delays.
Safety compliance: Adherence to safety procedures
Staff development: Completion of required training and improvement in staff competence.
Audit readiness: Timely closure of assigned audit findings and CAP
Housekeeping and hygiene: Compliance with production-area cleanliness and hygiene standards.
Qualifications and Experience
Bachelor of Pharmacy (B.Pharm) or Doctor of Pharmacy (Pharm.D.) from a recognised institution.
Current registration and practising licence with the Pharmacists Council of Nigeria (PCN), as applicable to the position and duties.
Minimum of 2 - 5 years of relevant experience in pharmaceutical manufacturing or production.
Demonstrated experience in pharmaceutical production processes and batch documentation.
Good knowledge of cGMP, SOPs, GDP, and pharmaceutical quality systems.
Experience with production equipment, process controls, and manufacturing documentation.
Familiarity with applicable NAFDAC Requirements and pharmaceutical Regulatory standards.
Experience in oral solid dosage forms, liquids, capsules, tablets, or other relevant dosage forms is an advantage.
Required Skills and Competencies:
Strong leadership and personnel management skills.
Good analytical, problem-solving, and decision-making abilities.
Excellent documentation and report-writing skills.
Strong attention to detail and commitment to product quality.
Good communication and Interpersonal skills.
Ability to work under pressure and meet production deadlines.
Good understanding of GMP compliance and quality risk management.
Proficiency in Microsoft Office and production reporting systems.
Reporting Relationship:
Reports to: Production Manager or Head of Production.
Supervises: Production Supervisors, Line Leaders, Machine Operators, and other assigned production staff.
Works closely with: Quality Assurance, Quality Control, Engineering and Maintenance, Warehouse, Regulatory Affairs, and Supply Chain departments.
Working Conditions:
Work is primarily within pharmaceutical manufacturing facilities.
May require the use of protective clothing and entry into controlled production areas.
May involve shift work or extended hours depending on production schedules.
Must comply with all company safety, hygiene, and quality requirements.
General Responsibilities:
The Production Pharmacist shall perform other reasonable duties assigned by management that are consistent with the position, professional competence, and applicable regulatory requirements.