Job title
:
CHC EM QA Manager
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 www.opella.com
About The Job
Responsible for the overall operational activity for the CHC group CMO for the timely release and supporting for resolution to QA managers for the Issue and queries resolutions.
Main Responsibilities
- CGMP compliance at CMO & Release of products
- Ensure all Operational aspects of the manufacturing of pharmaceutical products at identified CMOs comply with the requirements of the Opella Quality directives and meet all relevant cGMP & regulatory requirements.
- Monitor and ensure that all drug products are timely released in accordance with the registered specifications and are released to the market in accordance with local regulations.
- Ensure that coordinated contact is maintained with other functions within Opella namely Purchasing, Legal, Supply Chain, Drug Regulatory Affairs, and Marketing for timely operational compliance and release of product.
- Responsible for assessing Quality trends and driving Continuous improvement for processes and product quality performance.
- Escalate all potential quality issues and initiate all actions as defined for Gap closer
- Quality Agreements
- Ensure all QAG updated and are available in VEEVA - Connect VEEVA - Connect VEEVA - Connect for the assigned Group of CMO’s.
- Maintain a valid QA agreement which is in line with the Global template clearly defining cGMP roles and responsibilities between Opella and the CMO’s, for applicable products. Perform the required periodic review and negotiation with CMO and make recommendations for amendments to the agreement based on identified needs and issues.
- Audit Management
- Responsible for performing quality audits of CMOs and suppliers of raw and packing materials and ensuring that Quality Audits are carried out as per allocation according to the defined frequencies and Annual calendar.
- All critical and major findings to be discussed with Lead Quality on timely manner for the appropriate action plan.
- Prepare Audit report within timeline and upload in VEEVA – Connect and Ensure closure for corrective and preventive action plans for audit findings and timely updated in VEEVA - Connect.
- Product Technical Complaints
- Timely coordinate and communicate the PTC to CMO’s for investigation
- Actively participate in the Product Technical complaint investigation with the CMO for the investigation of product technical complaints
- Closely work with the central cell for identification of appropriate CAPA and implemented timely manner at CMO.
- Closely coordinate with central cell for timely closer of PTC within timeline.
- Responsible for overall PTC of assigned group of CMO’s for timely closer and investigations and support QA manager for defining appropriate CAPA
- Responsible for cause audit whenever required for the market complaint.
- Quality Management System Compliance
- Responsible for maintaining all relevant QMS applicable for group of CMO’s with the help of Central cell.
- Participate and guide QA managers for appropriate evaluation and implementations of QMS at CMO’s.
- Manage all Quality Issues (Deviations, complaints, OOS, recalls, counterfeit, stability failures, critical risk etc.) according to the Quality Management system defined as per EM SOP and Sanofi CHC Global SOP’s.
- Provides timely information to Center cell QMS on above quality event for registration in appropriate system e.g. VEEVA - Connect
- Actively participates in evaluation and defining CAPA / action plan / Investigations and agrees with plan and its implementation time lines with Center cell QMS.
- Executes / Implements at CMO the task assigned in VEEVA - Connect for relevant quality event, CC, investigation, CAPA, action item etc.
- Ensure investigations/actions plans /CAPA’s are correctly executed in timely manner at CMO site as well as EM India organization as applicable.
- Ensure verification of implementation of identified CAPA at CMO during site Quality review visits.
- Ensure the compliance of the product through testing as per specification, change management, stability studies, deviation and investigation, OOS and market complaint systems.
- Responsible for assessing Quality trends through APQR’s and driving Continuous improvement for processes and product quality performance. To ensure validations, qualifications at CMO site.
- Ensure all APQR’s are received in timely manner as per APQR calendar and are assessed with in timeline.
- Ensure all APQR are meeting requirement as per Sanofi CHC SOP and Global directive
- Quality reviews
- Responsible for the timely completion of the SQR calendar for group of CMO’s.
- Define and implement Quality improvement plan for the group of CMO’s
- Ensure all Quality reviews are conducted for the CMO assigned as per the SQR calendar.
- Quality review visit reports are prepared timely manner and are discussed with Lead Quality for the observations and actions taken during the Site Quality reviews.
- Ensure the Product approved Dossier and Pharmacopeia are appropriately implemented for the products manufactured at CMO.
- Identify the gaps and draw an action plan by discussion with head QA. Ensure implementation of action plan timely manner
- Regulatory compliance and Inspection
- Responsible for the regulatory status of the group of CMO’s by ensuring implementation of correct Dossier and cGMP
- Ensure to maintain Quality and regulatory compliance of CMO allocated, by On-Site Quality review as per planner.
- Ensure audit readiness at CMO for regulatory audits at CMO’s.
- Ensuring timely completion of the compliance to the local and export regulatory audits of the contract manufacturing sites.
- New Drug Product –Quality Evaluation
- Evaluate the new drug product sites for new product evaluation and follow up compliance to ensure the timelines of product launches
- Review of product-quality dossiers and conclude on outcome and approval
- Identify the gaps and draw an action plan by coordinating with CMO. Ensure implementation of action plan
- Project Management
- To lead, participate, support the projects of technology transfer/Continuous Improvement projects for new products or existing products identified and allocated as per project Management.
- Ensure compliance to Opella’s Technology Transfer standards, procedures and applicable cGMP and regulatory registration (dossier) as required.
- Ensure smooth analytical and manufacturing transfer through close working with transferring site and receiving site.
- Ensure for timely feedback and update on status of projects allocated to project management team.
- Conduct due diligence or cGMP audit of new site as a prospective sub contractor, evaluate & approve new product dossiers.
- Perform Quality Risk assessment
- Responsible for identifying the Risk and investigating for identification of appropriate CAPA for group of CMO’s
- To continuously evaluate the quality risks and escalate all potential quality issues and risks and initiate all actions as defined.
- Closely work with central QMS cell to Perform Quality Risk assessment as necessary for critical quality issues.
- Conduct investigation for the critical risk and timely feedback to Central cell.
- Conduct the CMO risk ranking as per the frequency for the assigned CMO’s. Timely discuss and align the Action plan for the improvement of CMO risk ranking with Lead Quality.
- Other responsibility
- Ensure a cross-functional alignment within the firm, mainly with EM, and with the assigned CMOs to safeguard and control all processes required for receiving products from CMOs in terms of quality, compliance, time, volumes, and costs during the overall contract life cycle.
- Ensure to have regular meeting to discuss with Supply Chain coordination to discuss and resolve operational issues
- Escalation of issues to the Lead Quality and Head EM to resolve conflicts as and when required
- Drive continuous improvement projects for CMO improvements
About You
Experience:
- In depth knowledge of pharmaceutical/nutraceutical/cosmetics/medical devices GMP and regulations (ASEAN, EU, ICH, PIC/S, local market GMP regulations)
- 15 years+ relevant experience
- Able to write technical reports
Skills
- Ability to work in a matrix organization.
- Good team spirit and familiar with project development through cross-functional activities
- Strong organizational and negotiation skills
- Pro-active with good sense of responsibility
- Balanced Judgment / Risk based approach
- Analytical thinking, hands-on troubleshooting style
Education
- M.Pharma from reputed college or Graduate in B.Pharma
Languages
- Strong interpersonal and communication skills (writing & verbal) with excellent command of English
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.www.opella.com/en/careers
