QA Manager Pharmaceuticals & Healthcare

Rozee Sales Demo

PKR 300,000 • Published Date: • Karachi, Pakistan (On-Site)

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Description

Rozee Sales Demo is seeking a Quality Assurance Manager to lead quality systems and regulatory readiness across pharmaceutical and healthcare operations. The role ensures that products, processes, facilities, records, and business practices meet applicable requirements and the company’s quality standards. The manager builds and maintains effective systems for Good Manufacturing Practices (GMP), Quality Management Systems (QMS), regulatory compliance, audit and inspection readiness, corrective and preventive action management, validation and qualification, quality risk management, and documentation. The position requires at least 10 years of relevant experience in pharmaceutical or healthcare quality assurance, a strong understanding of regulated operations, and the ability to turn requirements into clear, practical procedures. The manager assesses quality events, identifies risks, drives timely corrective action, and verifies that improvements work as intended. The role works with operational and technical stakeholders to prevent quality issues while supporting safe, consistent, and compliant products and services. 

The Quality Assurance Manager leads a team of five people, setting clear priorities, assigning work, coaching team members, and reviewing the quality and timeliness of their output. The manager promotes accountability, sound judgment, and consistent application of procedures across the team. The role provides quality oversight throughout the product and process lifecycle, from supplier and material controls through manufacturing, testing, release, storage, and distribution, as applicable to company operations. It also maintains inspection-ready records, coordinates responses to auditors and regulatory inspectors, and reports significant risks and performance trends to company leadership. Success in this position means that quality responsibilities are understood, issues are addressed at their source, records are accurate and complete, and improvement actions produce sustained results.

Responsibilities

- Lead and maintain the company’s pharmaceutical and healthcare quality systems, ensuring that documented processes support applicable regulatory requirements, internal standards, and Good Manufacturing Practices. 
- Translate regulatory and quality requirements into clear policies, procedures, work instructions, forms, and training materials that employees can apply consistently.
- Review quality systems regularly to confirm that they remain suitable for the company’s products, services, facilities, processes, and operating risks.
- Establish annual quality priorities and practical goals, then monitor progress through defined measures, periodic reviews, and documented follow-up.
- Provide independent quality oversight of manufacturing, laboratory, packaging, storage, distribution, and other regulated activities that apply to the business.
- Review and approve controlled documents, including procedures, specifications, protocols, reports, forms, and records, for accuracy, clarity, completeness, and alignment with requirements.
- Maintain document control processes that manage drafting, review, approval, release, revision, retention, access, and archival of quality records.
- Ensure records are attributable, legible, contemporaneous, original, accurate, complete, and retrievable, and address gaps or errors through appropriate correction and investigation processes.
- Oversee deviations, nonconformances, complaints, out-of-specification results, and other quality events from initial reporting through investigation, action, approval, and closure.
- Ensure investigations establish the facts, evaluate product and patient or user impact, identify direct and underlying causes, and determine whether other products, processes, or records may be affected.
- Direct corrective and preventive action management, including action planning, assignment of accountable owners, due-date monitoring, evidence review, and effectiveness checks.
- Escalate overdue, ineffective, or high-risk actions and ensure that management understands the impact, proposed response, and remaining risk.
- Review recurring events, complaint trends, audit findings, and performance data to identify patterns and prioritize preventive improvements.
- Apply quality risk management methods to assess hazards, rank risks, determine appropriate controls, and document decisions in a way that supports consistent, evidence-based action.
- Ensure risk assessments are updated when processes, materials, suppliers, equipment, facilities, systems, or regulatory expectations change.
- Establish and oversee validation and qualification plans for facilities, utilities, equipment, manufacturing processes, cleaning processes, analytical methods, and computerized systems, as applicable.
- Review validation protocols and reports to confirm that acceptance criteria are defined in advance, results are supported by evidence, deviations are resolved, and conclusions are justified.
- Maintain the validated state of processes and systems through change control, periodic review, monitoring, and requalification where needed.
- Oversee change control from request through impact assessment, approval, implementation, verification, and closure, ensuring that required testing, training, documentation, and regulatory assessments are completed.
- Assess the quality and compliance impact of changes to products, suppliers, equipment, facilities, procedures, software, processes, and organizational responsibilities before implementation.
- Plan and coordinate internal audits and supplier audits using a risk-based schedule, clear audit criteria, qualified auditors, and documented procedures.
- Conduct or oversee audits that assess actual practices as well as written procedures, and record objective evidence in clear, fair, and actionable findings.
- Track audit findings through corrective action and effectiveness review, escalating significant or repeated weaknesses to company leadership.
- Maintain inspection readiness by keeping current records organized, ensuring staff understand their responsibilities, and confirming that facilities and processes demonstrate compliance in routine operation.
- Coordinate preparation for regulatory inspections and customer or certification audits, including schedules, document requests, meeting arrangements, subject matter support, and response tracking.
- Serve as a point of coordination during inspections, ensure requests receive accurate and timely responses, and maintain a clear record of information provided.
- Lead the preparation, review, and approval of inspection responses and ensure that commitments are realistic, evidence-based, assigned, and completed on time.
- Manage product quality complaints and other customer-reported quality concerns in accordance with defined procedures and applicable reporting obligations.
- Ensure complaint assessments consider potential product impact, health or user risk, reportability, investigation scope, corrective action, and communication needs.
- Oversee product disposition and release controls, confirming that required records, test results, approvals, and investigations are complete before release decisions are made.
- Support decisions concerning quarantine, rejection, rework, return, recall, or other product controls, ensuring that decisions are documented and approved by authorized personnel.
- Establish and maintain supplier quality controls, including qualification, risk classification, performance monitoring, audit planning, quality agreements, and periodic reassessment.
- Review supplier issues and material failures, coordinate investigations with relevant parties, and verify that corrective actions address the cause and protect product quality.
- Ensure incoming materials, packaging components, and outsourced services meet approved specifications and acceptance requirements before use.
- Review quality agreements and define clear responsibilities for quality activities, records, change notification, deviations, complaints, audits, and regulatory support.
- Oversee training requirements for quality-related roles, maintain training records, and verify that employees are qualified before performing assigned tasks.
- Identify training needs arising from new or revised procedures, audit findings, errors, quality events, and changes in regulatory or operational requirements.
- Provide practical guidance to employees on quality expectations and encourage early reporting of concerns without compromising investigation integrity or accountability.
- Lead, supervise, and develop a team of five people by setting expectations, assigning responsibilities, reviewing workload, and providing timely coaching and feedback.
- Match team assignments to capability and priority, ensure appropriate coverage for critical quality activities, and address capacity or skill gaps through development planning.
- Review team work for sound reasoning, completeness, compliance, and consistent application of procedures, while giving team members ownership of their assigned outcomes.
- Build team capability through instruction, cross-training, knowledge sharing, and exposure to audits, investigations, validation work, and quality improvement activities.
- Promote a respectful, fact-based quality culture in which employees understand their responsibilities and raise risks promptly.
- Work with manufacturing, laboratory, engineering, supply chain, regulatory, clinical, commercial, and customer-facing functions as relevant to resolve quality matters and prevent recurrence.
- Provide quality advice early in planning and decision-making so that new products, processes, equipment, suppliers, and services include appropriate controls from the outset.
- Review product and process performance data, including deviations, complaints, audit results, supplier performance, training status, and corrective action completion.
- Prepare clear quality reports and management review materials that summarize performance, significant risks, open actions, emerging trends, resource needs, and recommended decisions.
- Use suitable quality metrics to assess system health and identify areas for improvement without relying on measures that obscure risk or encourage incomplete reporting.
- Lead or support continuous improvement projects that simplify workflows, improve record quality, strengthen controls, reduce preventable errors, and sustain regulatory compliance.
- Verify that improvements are supported by evidence, approved through the appropriate process, communicated to affected personnel, and monitored after implementation.
- Stay informed about applicable changes in pharmaceutical and healthcare quality requirements and assess their impact on company procedures, training, products, and operations.
- Coordinate implementation of approved regulatory updates and maintain evidence that affected processes and personnel have been brought into compliance.
- Protect confidential product, customer, supplier, employee, and business information handled through quality activities.
- Make timely decisions within the authority of the role, document the basis for significant quality decisions, and refer matters beyond that authority to the appropriate level of leadership.
- Perform other quality assurance duties that are consistent with the role, the company’s regulated activities, and applicable requirements.

Experience

10 Years

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Required Skills

Nice to Have Skills