Quality Assurance Manager at Ascendis Health

JOB OBJECTIVE:

• Ensure the Quality of all ACB products.
• Develop, improve and manage the Quality Management Systems (QMS)
• Ensure that Standard Operating Procedures (SOPs) are current and appropriately implemented
• Continued improvement to meet industry best practice
• Assist the RP with both Quality Assurance (QA) and Regulatory Affair (RA) activities
• Deputise for the RP in his/her absence.

KEY RESPONSIBILITIES

• Maintain and implement a robust QMS
• Manage the Quality aspects of all third parties.

JOB DESCRIPTION

• Ensure compliance with the legislative requirements as set out in Act 101 of 1965 and Pharmacy Act 53 of 1974 and all regulations and guidelines pertaining to current Good Manufacturing Practices (cGMP)
• Conduct quarterly Quality Management Review meetings reporting on all aspects of the QMS
• Maintain, improve and manage the QMS
• Ensure that cGMP is maintained for all products, processes and third parties
• Ensure SOPs are drafted, maintained and distributed to the team
• Ensure SOPS are adhered to
• Approve and release for sale to the market, the finished products, as delegated by the RP.
• Ensure QA compliance of documentation, by reviewing and authorising relevant SOPs, master document, technical agreements and contracts
• Ensure all master documentation is updated, current and approved
• Participate in the artwork approval process
• Manage the investigation, reporting and closure of all out of specifications, deviations and non-conformances.
• Oversee the change control process and ensure closure of all change controls
• Monitor the Corrective and Preventative Actions (CAPA) associated with ACB products
• Manage the product stability testing process
• Oversee the validation requirements
• Investigate and report on technical customer complaints and queries, where relevant
• Perform third party, vendor, supplier and internal audits and monitor audit CAPAs
• Co-ordinate and perform Periodic Product Reviews on all ACB products
• Participate in the new product development process, especially to ensure trial batches, stability and validation requirements are adhered to
• Supervise QA support staff
• Responsible to train all relevant staff on SOPs and other quality aspects
• Perform duties and tasks as delegated by the RP
• Without detracting from specific tasks and duties referred to in the job description, required to comply with any reasonable requests or instructions from the RP and Head of Regulatory related to company functions from time to time.

SUPERVISION EXERCISE

• This position will be responsible for managing two direct reports
• You will be responsible for leading your team, training and development of you staff as well as conducting performance reviews, etc.

QUALIFICATION AND SKILLS

• Minimum Bachelor of Pharmacy
• Registered with the South African Pharmacy Council
• 5 to 10 years’ experience in quality assurance in a pharmaceutical or nutraceutical environment.

INHERENT REQUIREMENTS

• Ability to prioritise workload to tight deadlines
• Problem solving and decision-making ability
• Ability to analyse and evaluate data
• Self-motivated individual
• Excellent written and verbal communication skills
• Excellent communication and interpersonal skills within a team context
• Provide leadership, guidance, and management as required
• Act with integrity – honour commitments, take responsibility for decisions, and behave consistently
• Maintain appropriate communication within and between the different functional areas in the broader team.