Swiss Pharmaceuticals Pvt. Ltd., a well-established leader in Pakistan’s pharmaceutical industry for over 30 years, is seeking a Quality Assurance Manager to join its manufacturing facility in Karachi. Founded in 1990 and revitalized under the leadership of Chairman Hafiz Ferozuddin since 2009, the company operates a modern production site that manufactures a diverse portfolio of products, including tablets, capsules, injectables, syrups, ointments, cephalosporins, and nutraceuticals. Swiss Pharmaceuticals also provides contract and toll manufacturing services to international markets, with a strong focus on innovation, quality, and customer satisfaction. The Quality Assurance Manager will play a critical role in maintaining and enhancing the company’s commitment to delivering safe, effective, and high-quality healthcare products.
Key Responsibilities
- Implement, monitor, and continuously improve quality assurance systems to ensure compliance with Good Manufacturing Practices (GMP), regulatory standards, and internal company policies.
- Develop, review, and update Standard Operating Procedures (SOPs) to reflect current regulatory requirements and operational best practices.
- Supervise and coordinate quality audits, ensuring thorough documentation and timely resolution of findings.
- Manage deviation investigations and Corrective and Preventive Action (CAPA) processes, including root cause analysis and follow-up activities.
- Review batch production records and product documentation to support product release decisions.
- Collaborate closely with cross-functional teams such as production, quality control, regulatory affairs, and supply chain to address quality issues and mitigate risks.
- Lead training programs and mentor Quality Assurance staff to enhance team capabilities and maintain high standards.
- Prepare for and support regulatory inspections as well as customer audits, ensuring readiness and compliance.
- Contribute to strategic quality initiatives aimed at improving overall operational excellence and product quality across the organization.
Required Qualifications
- Strong expertise in pharmaceutical quality systems, including GMP compliance, documentation control, SOP development, and batch record review.
- Proven experience in conducting quality audits, managing deviations, performing root cause analysis, and planning and executing CAPA activities.
- In-depth knowledge of regulatory requirements applicable in Pakistan and international markets, along with familiarity with validation and qualification processes.
- Demonstrated ability to work effectively with cross-functional teams, including production, QC, regulatory affairs, and supply chain.
- Excellent analytical, problem-solving, and decision-making skills, with a keen eye for detail and a commitment to continuous improvement.
- Strong written and verbal communication skills for preparing reports, documentation, and delivering staff training.
- Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related discipline.
- Several years of progressive experience in pharmaceutical quality assurance, with prior leadership or supervisory experience highly preferred.
- Comfortable working in a fast-paced manufacturing environment handling multiple dosage forms such as solids, liquids, injectables, and nutraceuticals.
Swiss Pharmaceuticals offers an opportunity to contribute to a reputable and growing organization dedicated to advancing healthcare through quality and innovation. The role provides a challenging and rewarding environment for a quality assurance professional seeking to make a meaningful impact within the pharmaceutical manufacturing sector.