Global Quality CHC

Job title
: Global Quality CHC - Auditor

• Location: Hyderabad

Opella is the self-care challenger with the purest and
third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally
.

Our mission is to bring health in people's hands by
making self-care as simple as it should be
. For half a billion consumers worldwide – and counting.

At the core of this mission is our
100 loved brands
, our
11,000-strong global team, our 13 best-in-class manufacturing sites
and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world's most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan.

B Corp certified in multiple markets
, we are active players in the journey towards healthier people and planet. Find out more about our mission at

About The Job
Mission & Tasks

• Support Quality Audit Programs including development, scheduling, and implementing plans for comprehensive quality system audits taking into consideration quality metrics, results of previous quality audits and external inspections, industry trends and the external regulatory environment.
• Collect, collate, and incorporate input into the audit strategy and plan. Plan, lead, conduct, document, and follow-up of GMP audit according to the requirements specified in the respective Opella Quality procedures as well as applicable regulations, standards, quality agreements, and guidance documents.
• Prepare audit reports according to Opella requirements and timelines. Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to Opella requirements on Management Escalations and other relevant procedures.

Main Responsibilities
Management Responsibilities:

• Coordinates and conducts routine and focused quality system audits as assigned to assess compliance with domestic and international regulations and standards, and corporate, and local procedures and policies.
• Conducts Quality Audits to assure compliance with domestic and international pharma standards and regulations, local procedures, and corporate policies/procedures.
• Follows up with the auditee as required to compile information relating to the audits.
• Evaluates the adequacy of the provided evidence against the approved Audit Action Plan (AAP).
• In conjunction with management, develops plans to address inadequate AAP documentation when required.
• Maintains the audit system software database to record the status of all audits and associated actions.
• Provides periodic reports to management based on the audit statuses and defined metrics.
• Maintains a high degree of personal professional development through a combination internal and external training and participation in professional associations as appropriate.
• Interacts with individuals at various levels of the organization across multiple sites/BUs and at Opella Leadership during and when following up on audits.
• Interfaces with local leadership teams and compliance personnel to establish and implement schedules for corporate audits and gain acceptance/understanding of identified non-conformances without damaging the relationship with the site or entity.
• Act as a local quality contact between the Suppliers, Global Quality-Suppliers & third-party sites to facilitate follow up of improvements and exchange of quality information.
• Participate in qualification of new auditors in the group, by performing audits with them and providing expertise regarding quality assessment of suppliers.
• Support audits led by other auditors when specific expertise is needed (e.g. for cause audit with user site representative, highly sophisticated topics)

Latitude Of Action

• Be instrumental in the development of Opella Annual Audit Schedule (OAAS) and mechanisms to assure on-going compliance.
• Organize day to day agenda according to workload defined by the group. Establish monthly reports and indicators for priority decision-making.
• Provision of impactful reports to Opella Global Quality for improving compliance, efficiency & performance.
• Provide regular reports and indicators to Opella Global Quality for workload and agenda priority decisions.
• Prepare audit reports according to Opella requirements and timelines. Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to Opella requirements on Management Escalations and other relevant procedures.

Role Impact

• Key role within Opella M&S, regarding quality assessment of Opella entities, activities, suppliers and CMOs on behalf of the Industrial Operations.

Scope

• Lead and perform Quality Audits of Opella entities, suppliers of Pharmaceutical Starting Materials packaging materials & Pharmacovigilance & Clinical activities located in the region and border countries on behalf of Opella M&S sites using these materials and located outside this country.

About You
Required Experience

• Operational experience regarding following technical field: Production or quality in Pharmaceuticals, chemistry, analytical, information system and supply chain at least with 10 years of experiences
• c-GMP and API Auditors certified with a preference for Pharmaceutical Lead Assessor status
• Preferable to also have experience in Pharmacovigilance and GCP (Good Clinical Practice).

Required Skills

• Comprehensive understanding of auditing principles and ability to perform as a lead auditor.
• Demonstrated ability to effectively collaborate and partner with all levels of management while maintaining an appropriate assertive style is critical.
• Understands team functions, leadership techniques and project management methodologies.
• Understands how to present information to varying levels within the organization; strong analytical skills and effective project management and organizational skills are essential.
• Ability to make realistic diagnosis, question the evidence & challenge data from different sources
• Excellent ability to adapt quickly to unexpected situations and reorganize priorities on the spot and adapt the audit conduct according to findings.
• Excellent listening skills, interpersonal skills, ability to manage conflict and step back when required.
• Fluent in English, oral and written. Excellent communication skills (verbal, written, and presentation).
• Ready to travel at least 50% of time.

Required Skills And Experience

• B.S. Pharmacy, Chemistry, Biology or equivalent discipline, advanced degree is preferred.

Why us?
At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day.

We Are Challengers.
We Are Dedicated To Making Self-care As Simple As It Should Be. That Starts With Our Culture. We Are Challengers By Nature, And This Is How We Do Things

All In Together:
We keep each other honest and have each other's backs.

Courageous:
We break boundaries and take thoughtful risks with creativity.

Outcome-Obsessed:
We are personally accountable, driving sustainable impact and results with integrity.

Radically Simple:
We strive to make things simple for us and simple for consumers, as it should be.

Join us on our mission. Health. In your hands.