49 Manufacturing jobs in Sindh

The Opportunity

This role provides direction to the Manufacturing and Finishing Operations team at the Korangi Plant in Karachi. Reporting to the Operations Director, this position is responsible for ensuring compliance with local Regulatory requirements, cGMP, EHS & and Abbott Quality standards during manufacturing and finishing operations.

Core Job Responsibilities

• Prepare and Monitor Operational Plan for Optimum utilization of Resources i.e. Material, Labour & Overheads
• Ensure that products are manufactured under conditions that meet Abbott Policies, EHS Standards, and Regulatory and cGMP requirements.
• Ensure compliance with labor laws, security standing orders & code of Business conduct.
• Ensure provision of the necessary resources (area, equipment, workforce, etc.) to produce products of the required quality.
• Ensure that required initial and continuing training of production personnel including GMP training is carried out and adapted according to need.
• Provide strategic direction in Mfg. technology and equipment. Ensure that maintenance of premises and equipment, calibrations, and Process Validation are performed and recorded.
• Coordinate with Quality regarding QA Audits, CAPA, Complaints, ERs, Market Returns, and Trend Analysis Reports, etc.
• Coordinate with QA, Regulatory, Technical Centre, Engineering, and Supply Chain in the resolution of quality problems, disposition of nonconforming issues, and ensure uninterrupted product deliveries to Commercial.
• Prepare Plant annual budget in consultation with Finance and get it approved by Management.
• Take into account all demands, including forecasts, contracts, customer orders, samples, special prototypes, spares, interplant, etc in creating a Master Schedule that directs and drives all manufacturing, purchasing, and manufacturing-related engineering activities.
• Monitor KPIs and perform Root Cause Analysis where applicable.
• Review and approve technical documents including SOPs, Manufacturing and Finishing Directions including in-process controls, Shop Orders, Validation documents, Change requests, CAPA and ERs, etc.
• Ensure that the production records are re-evaluated and signed by a designated person before they are made available to the Quality Assurance department.
• Review new product dossiers and Manufacturing input for preparation of product registration / re-registration and their submission to the Regulatory Department.
• Review batch variance/yield reports with production managers and take appropriate steps for improvement.
• Expose, prioritize, and stimulate the reduction or elimination of non-value-added activities.
• Ensure employee development, Goal Setting, Performance Assessment, and succession planning within the department.
• Any other task assigned by Director Operations.

Qualifications

• B.Pharm/Pharm.D
• 10 years of working experience in Manufacturing and Finishing operations
• Knowledge of Drug Rules, cGMP requirements, and Quality Standards
• Understanding of Supply Chain Management of Multi-National Companies
• Awareness of Operational Finance and Capital Budgeting
• Understanding of Business Excellence (CI) and New Product Development activities

Competencies required:

• Good communication and Interpersonal skills
• Proven Leadership qualities
• Ability to thrive in a fast-paced environment

Location: SITE, Super Highway, Phase-II, Karachi

Position Overview:

The Quality Control (QC) Manager will be responsible for overseeing quality control activities in a medical device manufacturing facility, ensuring products meet high standards, regulatory requirements, customer expectations, and QMS compliance. This role includes managing a team, coordinating testing, improving quality processes, and supporting other departments like Quality Assurance and technical problem resolution. The QC Manager is also responsible for using and maintaining inspection methods and equipment to ensure timely and compliant results.

Key Responsibilities:

• Supervise and support QC inspectors and technicians to ensure adherence to company standards and prevent delays or product unavailability.
• Develop and implement quality control procedures to ensure compliance with ISO 13485 and DRAP regulations, demonstrating technical proficiency in analytical methodology and adherence to GMP and ICH standards.
• Ensure the timely disposition of raw materials, packaging materials, and finished products based on priorities set with Manufacturing, Marketing, and Materials Management, while overseeing inspection and testing to meet quality and efficiency standards.
• Review the daily QC Lab planning schedule. Monitor adherence to quality standards, regulations, and best practices. Perform regular audits of QC processes.
• Ensure the implementation of the product stability testing & evaluation as per SOP to verify shelf-life compliance and identify quality issues related to product stability.
• Gather and analyze quality data, generate reports, and suggest actions for quality improvement.
• Investigate quality issues or non-conformities and collaborate with other departments to resolve them.
• Oversee Quality Risk Management and Change Controls within the QC and Micro Lab domains, identifying areas for improvement and implementing changes to enhance product quality and manufacturing processes.
• Ensure all vendors are qualified and comply with vendor standards, collaborating with suppliers to maintain material quality and conducting evaluations and audits as necessary.
• Assist in preparing for and participating in external audits and inspections, providing required documentation and evidence of compliance.
• Maintain accurate records of quality control activities, including inspection and testing reports.

Required Skills and Qualifications:

• Must have a pharmacy, biomedical engineering, or biotechnology degree recognized by HEC.
• A minimum of 5-6 years of experience in quality control and testing, preferably within a medical device manufacturing environment, with at least 4 years in a supervisory position.
• Certification in quality control or quality management systems (e.g., CQE, CQA) is preferred.
• In-depth knowledge of ISO 13485, DRAP regulations, and other relevant standards for medical device manufacturing.
• Exceptional leadership and team management skills, strong analytical and problem-solving abilities, meticulous attention to detail, and effective communication skills required.

This position offers a unique opportunity to work in a dynamic and challenging environment where you can apply your skills and experience to drive improvements and ensure the success of the Quality Control Department.

Application Process:

Please submit your CV/Resume detailing your experience and qualifications with the subject line ‘QC Manager’.