Quality Control Manager

Virbac.com

Office

Full Time

Experiencing together a unique human adventure

Animal health is key to the health of the planet. Working at Virbac means taking part in a unique human adventure in which the engagement of each individual contributes to its evolution. Encouraging internal mobility between positions and countries, offering individual development plans and building a partnership based on trust between managers and employees are as many perspectives of motivation for our teams. We also offer them a work environment conducive to exploring new territories and balancing their professional and personal lives. Finally, fostering their engagement to animal health also means listening to them and helping them to acquire new skills, preparing them for the challenges of tomorrow and encouraging them to contribute to an ever more responsible approach to our business.

Supervise and carry out all laboratory activities involved with the analyses of materials and products to cGLP/cGMP standards. Maintain QC infrastructure to ensure timeous and accurate analytical results for all products to meet customer and cGxP requirements.

Managing a team of laboratory staff and developing operating procedures to ensure that experiments and analyses are conducted within budgets and according to established scientific standards
Prioritizing and allocating laboratory operations and workflow so that the laboratory’s equipment and resources are used efficiently and work schedules and targets are met
Researching, evaluating, and recommending investments in technology, equipment, systems, or other assets that will enhance the laboratory’s performance

Management Of People

Propose resource requirements and appropriate organisational structure to meet strategic missions, critical success factors and business outcomes for the department. Manage and support the recruitment of staff with the right experience, competencies that fit with the Virbac culture.
Provide ongoing feedback and coaching to direct reports in order to ensure they meet the expectations of performance, and to develop and support them in their role.

Quality Control

Allocate work to the focus stations in the Quality Control Laboratory. Optimise testing costs and throughput times according to continuous improvement objectives.
Check and sign-off all laboratory results of testing conducted by Laboratory Analysts including a check to ensure the correct method was used and reviewing of raw data.
Ensure that all errors, overwriting and blank spaces on worksheets are deleted and signed for per SOP (14)9 Good Documentation Practice.
Ensure that all HPLC printouts are initialled and dated by the Lab Analyst and the reviewer.
Ensure that the necessary QC documentation is maintained in line with current Good Laboratory Practice (cGLP).
Ensure that information is completed on the Trending spreadsheet for API, FP and RO water
Ensure analyses are conducted timeously according to prescribed methods and plan, with priority given to backorder and essential products.
Ensure that the weekly Laboratory Schedule is updated twice a week.
Communicate any delays in testing to the relevant stakeholders within 1 day of identifying the delay.
Ensure that products are tested within their agreed timelines as per the Laboratory Schedule.
Ensure analytical methods are validated as per the required schedule.
Ensure analytical method transfers are planned and completed as per the required schedule
Ensure laboratory productivity and efficiency to meet business requirements.
Compile, maintain and update the Products in Q sheet.
Ensure that reagents, reference standards and other consumables are ordered at least 1 month before expiration or consumption to avoid delays in release.
Ensure that POs and Tax Invoices are submitted for payment
Maintain high standards of cGLP at all times.
Conduct method development as required.
Ensure out of specification reports are initiated immediately when an OOS is identified and investigated.
All OOSs must be immediately communicated to the relevant stakeholders.
Ensure that there is an annual inhouse Lab Plan in place for the following year by the end of Q3 of each current year.
Perform analysis where an analyst is not available or as dictated by the workload.
Any other requests as deemed reasonable by your Manager

Documentation Management

Ensure that analytical methods are current and aligned to the dossier.
Ensure that the filing system is in place to ensure safe storage and easy retrieval of documents related to analytical processes.
Ensure that Laboratory Analysts compile all Laboratory Reports as the prescribed SOP.
Ensure that Laboratory Analysts file all Laboratory Reports and raw data after completion of each analysis.
Ensure both computer generated and hard copy documentation are filed accurately according to cGLP and Good Documentation requirements
Ensure that all computer generated documents are backed up and easily retrievable.
Ensure that all Laboratory Reports and raw data are archived annually.
Draw up certificates of analysis (lab reports) as required.

Compliance

Ensures cGLP, Health & Safety and housekeeping codes are enforced according to appropriate procedures.
Ensure that Standard Operating Procedures are in place and up to date and adhered to for all critical activities as prescribed by the guidelines.
Ensure no critical findings during external audits by external parties.
Ensure closure of 90% of current self-inspection audit findings within a 12 month period.
Participate in investigations relating to product quality complaints, OOS, Root Cause Analysis and similar which affect the QA department.
Ensure staff are trained on cGLP and SOPs as required.
Compile, review and update of SOPs related to your function. Ensure that these SOPs are updated within the review date.
Complete training of personnel for SOPs where you are the initiator/ trainer.
Ensure that all corrective and preventative actions, deviations and change controls are closed within the agreed timeline.
Download and review of the temperature monitoring data for the laboratory and reference standard fridge on a weekly basis.
Report any temperature excursions to the Quality Manager immediately.
Submission of the temperature monitoring data to the Quality Manager on a monthly basis for review and approval.

Asset Management and Housekeeping

Adhere to the NIP process when procuring new equipment, instruments or NIP related items.
Ensure equipment is maintained and calibrated and qualified as per predetermined plan and is in good working order.
Motivate for new/replacement equipment and infrastructure.
Deploy equipment and related resources to maximize output.
Ensure that Laboratory equipment efficiency targets are met.
Ensure that housekeeping is completed as per the prescribed SOP.
Ensure that safety standards are maintained.
Ensure adherence to calibration and preventative maintenance schedule.
Ensure laboratory waste is disposed of in an environmentally responsible manner.

Reporting

Preparation of a monthly report on the laboratory's activities including but not limited to output, capacity, compliance, human resource and specific projects in progress within the department.
Submission of report to Quality Manager 1 working day before the meeting.

Budget Management

Operate within approved OPEX/CAPEX budgets.
Review departmental expenses monthly and plan accordingly to ensure compliance to set budget.

Requirements

National Diploma in Analytical Chemistry
BSc Chemistry or B Tech Chemistry equivalent qualification (NQF 7) – preferred
Supervisory/ team leader experience
5 years Pharmaceutical Laboratory experience with team leadership and cGxP compliance experience (minimum 5+ years Pharmaceutical laboratory experience with at least 2 years supervisory and cGxP compliance experience

Virbac provides numerous career opportunities, thanks to the diversity of its jobs and their international dimension.Joining Virbac means joining dynamic teams ambitious for success.Add Your Talent to Ours!