Quality Control Manager

2 weeks ago

Newcastle, KwaZulu-Natal, South Africa Nbisa Recruitment Full time

Guided by its purpose to provide products for patients to alleviate pain and suffering and improve their quality of life, NBI's vision is to be the leading African manufacturer and supplier of quality therapeutic proteins and diagnostic products. National Bioproducts Institute NPC has a vacancy for the role of Manager: Quality Control.

The successful incumbent will be required to contribute to the quality, safety, and efficacy of NBI's products through rigorous quality control processes, adhering to sound scientific principles and complying with current good manufacturing practice (cGMP).

Further, the QC manager is responsible for the smooth, efficient day-to-day operation of the QC laboratory, providing operational assurance in support of business and strategic requirements. Applications are invited from suitably qualified and experienced candidates.

  1. B.Sc in Chemistry, Analytical Chemistry or Biochemistry (Masters degree in Chemistry preferred)
  2. At least 5 years of Quality Control laboratory experience
  3. Minimum of 3 years' experience as a Quality Control Manager in a pharmaceutical or similar environment
  4. Complete understanding of cGMP, GLP and international pharmaceutical standards
  5. Hands-on experience with internal and vendor audits will be an advantage

Duties & Responsibilities

  1. QC department / laboratory management
  2. Plan and coordinate sample testing based on product specifications and production needs.
  3. Manage QC lab staff for timely analysis and reporting of raw materials and products.
  4. Report results in various formats, including certificates of analysis (CoAs).
  5. Ensure prompt release of raw materials and intermediate products for production.
  6. Develop and enhance internal quality control systems in line with GMP and industry standards.
  7. Implement and maintain an external proficiency testing program.
  8. Establish quality requirements and maintain in-house controls and reference standards.
  9. Review and approve QC activities and procedures for quality and compliance.
  10. Stay updated on cGMP requirements and regulatory expectations.
  11. Regularly review QC procedures to ensure best practices.
  12. Ensure adherence to scientific principles and proper statistical methods in QC analysis.

Specifications for all materials

  1. Approve, develop and maintain specifications for all materials used in pharmaceutical and diagnostic product production.

SAP and LIMS

  1. Ensure all SAP and LIMS transactions are completed as required for the release of raw materials, intermediates and final products.
  2. Perform SAP tasks as required by the quality management system and other business processes.
  3. Ensure LIMS and SAP is optimally set up and utilized to support effective, productive and efficient QC laboratory operations, and identify opportunities for further improvement to maximize LIMS functionality.

Analytical methods and QC equipment

  1. Assess the feasibility and benefits of new analytical methods, preparing justifications and CAPEX requests.
  2. Develop user requirement specifications for new QC facilities, equipment, and contract testing.
  3. Assist the Validation Team in preparing IQ, OQ, and PQ documents for qualification.
  4. Coordinate equipment qualifications and method validations, providing necessary documents to Regulatory Affairs for SAHPRA submissions.
  5. Oversee the implementation of new analytical methods and QC equipment post-SAHPRA approval, following NBI's change management procedures.
  6. Maintain a program for calibrating, servicing, and maintaining analytical equipment to ensure accuracy and prevent breakdowns.

Management of external / contract laboratories

  1. Identify and assess external laboratories for analytical testing as backup to in-house QC.
  2. Ensure contract laboratories use suitable and validated analytical methods.
  3. Audit contract laboratories per NBI's vendor management program.
  4. Review external testing service agreements.

Company strategy

  1. Contribute to company strategic plans and their implementation.
  2. Participate in strategic initiatives and continuity in leadership.
  3. Ensure alignment of the QC department with company-wide strategic initiatives.

Review and reporting of trends

  1. Monitor, analyze and report on trends of key QC performance indicators as part of monthly, quarterly and annual reviews and reports, including annual product quality reviews, or APQRs.
  2. Coordinate with applicable QC staff to ensure the monthly review of reference standards and in-house controls is performed, including statistical analysis and reporting of the trends.
  3. Ensure the appropriate use of sound statistical analysis of QC results.
  4. Prepare quarterly and annual reports on analytical results of raw materials, in-process and final product testing, as well as utilities.
  5. Attend quarterly and annual review meetings and provide input into the meetings as required.
  6. Coordinate with the Lead QC Analyst to ensure that stability reports are prepared, reviewed and shared with stakeholders.

Health, safety and the environment

  1. Ensure compliance to all relevant legislation e.g. Occupational Health and Safety Act.
  2. Coordinate the investigation of SHE incidents in the department, and identify and implement effective CAPAs to prevent recurrence.
  3. Ensure that NBI's procedure on waste management is being followed in the laboratory.

Support for other NBI departments

  1. Stay updated on advancements in analytical techniques for biopharmaceuticals to support interdepartmental discussions.
  2. Contribute to cross-departmental projects and troubleshooting with QC support and technical advice.
  3. Evaluate new raw materials, excipients, printed packaging materials, and closure systems for production support.
  4. Provide analytical support for new product development.

Maintain the quality system to ensure GMP compliance

  1. Ensure compliance to NBI's quality management system, GMP principles and SAHPRA guidelines in the QC department.
  2. Establish, review, and enforce SOPs for processes and analytical methods.
  3. Communicate QMS requirements to staff.
  4. Prepare for and participate in GMP audits by third parties and regulatory authorities.
  5. Conduct internal audits and implement corrective actions for continual improvement.
  6. Coordinate with QC staff to identify, document and implement CAPAs for non-conformances from audits and inspections.
  7. Collaborate with Quality Division managers to foster a culture of quality and uphold the NBI Quality Policy.
  8. Identify and implement continuous improvement initiatives, including annual Quality Objectives for the QC department and monitor progress.
  9. Coordinate out-of-specification root cause investigations per NBI's SOP and distribute reports to stakeholders.
  10. Coordinate customer complaint investigations, and prepare reports in compliance with NBI's SOP.
#J-18808-Ljbffr

  • Quality Control Manager

    4 days ago

    Newcastle, KwaZulu-Natal, South Africa THIRSTI Water Full time

    Thirsti Beverages requires the service of a suitably qualified and experienced Quality Control Manager to oversee all aspects of Quality Control at its world-class bottling plant outside Newcastle, KZN. The ideal candidate thrives in a driven, hard-working environment and must be solution-orientated with experience in the manufacturing and developing of...

  • Product Quality Control Manager

    7 days ago

    Newcastle, KwaZulu-Natal, South Africa Findojobs South Africa Full time

    We are on the hunt for a highly skilled Product Quality Control Manager to oversee the entire production process at Findojobs South Africa.About the Role:Quality Oversight: The successful candidate will be responsible for implementing quality control measures to ensure that all products meet the required standards.Inspection and Audit Schedule: Regular...

  • Call Centre Quality Control Supervisor

    7 days ago

    Newcastle, KwaZulu-Natal, South Africa Talksure Full time

    Talksure is seeking an experienced Call Centre Quality Control Supervisor to join our team. In this role, you will be responsible for overseeing the quality of our customer interactions, ensuring that we meet our service level agreements and deliver exceptional results.About the PositionThis position involves managing a team of quality control specialists,...

  • Quality Control Supervisor

    4 days ago

    Newcastle, KwaZulu-Natal, South Africa THIRSTI Water Full time

    We are committed to delivering exceptional quality and safety in everything we do at THIRSTI Water. As our Quality Control Supervisor - Beverages, you will play a vital role in achieving this goal.About the RoleThis is a hands-on position that requires a strong understanding of quality principles, processes, and systems. You will work closely with our...

  • Stocks And Quality Manager

    7 days ago

    Newcastle, KwaZulu-Natal, South Africa Redcat Recruitment Full time

    Description : RedCat Recruitment is seeking an experienced STOCKS AND QUALITY MANAGER for a large concern – position based in Richards Bay, KwaZulu-Natal.Job Description / RequirementsGrade 12.Valid driver's license / own reliable vehicle.Advanced MS Excel skills.National Diploma or Degree in Logistics or Production Management.5-10 years logistics /...

  • Food Safety and Quality Assurance Manager

    4 days ago

    Newcastle, KwaZulu-Natal, South Africa THIRSTI Water Full time

    At THIRSTI Water, we are seeking a seasoned Food Safety and Quality Assurance Manager to spearhead our quality control efforts. As a key member of our team, you will be responsible for ensuring that our products meet the highest standards of quality and safety.ResponsibilitiesOversee all aspects of quality control, including raw material receipt, production...

  • Quality Control Team Leader

    2 weeks ago

    Newcastle, KwaZulu-Natal, South Africa QIMA Full time

    Job ResponsibilitiesSupervise a team of 10-15 quality inspectors in Newcastle, South Africa, and oversee their performance through Key Performance Indicators. Take actions based on their results.Act as a trainer and coach, providing technical support and guidance to the inspectors, and conduct performance evaluations and onsite audits.Build a sense of...

  • Coal Quality Assurance Officer

    7 days ago

    Newcastle, KwaZulu-Natal, South Africa Redcat Recruitment Full time

    RedCat Recruitment is seeking a highly skilled Coal Quality Assurance Officer for a prominent concern in Richards Bay.Job OverviewGrade 12 is the minimum educational requirement for this position.A valid driver's license, reliable vehicle, and advanced MS Excel skills are essential.National Diploma or Degree holders in Logistics or Production Management with...

  • Inventory Control Specialist

    7 days ago

    Newcastle, KwaZulu-Natal, South Africa Redcat Recruitment Full time

    Description : RedCat Recruitment is seeking a highly skilled Inventory Control Specialist for a prominent concern in Richards Bay.Job Description / RequirementsGrade 12 is the minimum educational requirement.A valid driver's license and reliable vehicle are essential.Advanced MS Excel skills are necessary for efficient inventory management.A National Diploma...

  • Financial Controller

    2 weeks ago

    Newcastle, KwaZulu-Natal, South Africa Ignition Cx Full time

    Primary Purpose: This position is responsible for coordinating and administrating financial operations within the assigned business unit / area.The Financial Controller reviews, analyses and interprets financial reports.Key Roles and ResponsibilitiesFinancial Operations Leadership: Direct all aspects of accounting operations. Drive and lead the preparation...

  • Financial Controller

    2 weeks ago

    Newcastle, KwaZulu-Natal, South Africa Invictus Education Group Full time

    We're on the hunt for a proactive and detail-oriented Financial Controller to join our dynamic team.If you have a passion for numbers, a keen eye for accuracy, and the ability to drive financial excellence, this might be the perfect opportunity for youThe Financial Controller (FC) is responsible for supporting the financial operations of our...

  • Stock Controller

    2 weeks ago

    Newcastle, KwaZulu-Natal, South Africa LMP RECRUIT Full time

    Blue Marlin All-inclusive Seascape Resort is a premier South Coast holiday destination with a long-standing legacy. Situated at Blue Flag-certified Scottburgh Beach, this multi-room hotel is family-friendly and plays host to weddings and conferences.The Blue Marlin falls within Dream Hotels & Resorts, a mixed-use accommodation group working towards greater...

  • Construction Quality Assurance Manager

    6 days ago

    Newcastle, KwaZulu-Natal, South Africa South32 Limited Full time

    About South32: At South32, we're committed to building a brighter future through our focus on responsibly producing critical commodities for a low-carbon world.We offer a range of benefits, including annual short-term incentive bonuses that recognize both individual performance and overall business success. Eligible employees receive an employer contribution...

  • Manufacturing Process Quality Lead

    4 days ago

    Newcastle, KwaZulu-Natal, South Africa THIRSTI Water Full time

    We are seeking a Manufacturing Process Quality Lead to join our team at THIRSTI Water. This is a senior leadership position that requires a strong understanding of quality principles, processes, and systems.About the RoleYou will lead our quality control efforts, developing and implementing quality systems that align with GMP standards and drive business...

  • Senior Quality Assurance Manager

    1 week ago

    Newcastle, KwaZulu-Natal, South Africa Talksure Pty Ltd Full time

    About Us:Talksure Pty Ltd is a leading contact center solutions provider, committed to delivering exceptional customer experiences through innovative technologies and dedicated teams.Job Description:We are seeking a seasoned Senior Quality Assurance Manager to join our team. In this role, you will oversee call monitoring processes, gather actionable...

  • Controller Financial Management

    1 week ago

    Newcastle, KwaZulu-Natal, South Africa The Recruitment Guy (Pty) Ltd Full time

    Key Responsibilities:As a Controller Financial Management, you will be responsible for preparing accurate and timely financial statements, providing monthly analysis of financial performance, and maintaining the integrity and accuracy of the general ledger. You will also be required to prepare and submit group quarterly reporting, local and international...

  • Financial Planning and Control Manager

    7 days ago

    Newcastle, KwaZulu-Natal, South Africa Bga Recruitment Full time

    In this challenging yet rewarding role as Financial Manager at Bga Recruitment, you will have the opportunity to make a significant impact on the organization's financial success.The primary responsibility of this position is to manage the financial accounting team to ensure the effective preparation and interpretation of financial metrics, budgets, and...

  • Access Control Solutions Specialist

    2 hours ago

    Newcastle, KwaZulu-Natal, South Africa Assa Abloy Group Full time

    About UsHID Global powers the trusted identities of the world's people, places and things. We make it possible for people to transact safely, work productively and travel freely.We are seeking a highly skilled Access Control Solutions Specialist to join our team. As a key member of our organization, you will be responsible for ensuring the quality and...

  • Garment Quality Operations Manager

    7 days ago

    Newcastle, KwaZulu-Natal, South Africa QIMA Full time

    Company OverviewQIMA is a leading provider of inspection and testing services for the global supply chain. Our mission is to ensure the quality and compliance of products across various industries.

  • Testing and Quality Control Specialist

    7 days ago

    Newcastle, KwaZulu-Natal, South Africa Betsoftware Full time

    Required Skills and Qualifications:To be successful in this role, you will need to possess a BSc, BCom, or N.Dip degree and at least 3 years of QA-related experience. ISTQB certifications are highly advantageous.You must be a collaborative team player who engages actively in team efforts to achieve collective objectives. Adaptability and openness to change...