Technical Operations Manager

Company Description

C 2 PHARMA is the global leader in ophthalmic active pharmaceutical ingredients (APIs).

Founded in 2014 and headquartered in Cork, Ireland, C 2 PHARMA manufactures and

distributes APIs and complex chemical compounds obtained from synthetic and natural origins,

ensuring a reliable supply of high-quality APIs at competitive prices.

With our current API product portfolio, we reach more than 200 pharmaceutical companies across

the United States, Western and Eastern Europe, South America, Asia, Middle East, and Africa.

C 2 PHARMA also offers customized GDP-compliant cold-chain warehousing and logistics

solutions through its specialized affiliate Logistics4Pharma based in Frankfurt, Germany.

Visit our web page for more information: www.c2pharma.com Role Description

This is a full-time role for a Director of Technical Operations based in Hyderabad, India, Management position at C-SQUARED PHARMA INDIA PRIVATE LIMITED (“C2P India” or the “Company”): the role of Director of Technical Operations entails the following responsibilities for activities in India.

·      Oversee timely manufacturing activities at CMO’s for C2P products.

·      Lead resolution of technical issues at CMOs and external suppliers.

·      Manage and assist in trouble shooting activities at CMO for C2P products in relation to deviations, change controls, OOS results, yield losses, shifts in PSD, etc., with the respective Indian CMO’s / Service Providers

·      Assess and due diligence for new CMOs Contract Manufacturing Organizations and raw material suppliers.

·      Co-ordinate the execution of technical transfers of new APIs from development to selected and approved CMO’s.

·      Report and present regular updates to C2P management relating to commercial products, technical transfers activities and other strategic projects as required

·      Communicate critical issues to project stakeholders: highlight potential impacts on project timelines, demand, and supply.

·      Support C2P’s Quality and Regulatory Affairs teams in all technical matters, written technical justifications, etc., for DMF and CEP filings and registrations as required

·      Support CMOs during their pre-approval inspections (PAI) and routine quality inspections as may be related to C2P products as required.

·      Administer C2P India for all day-to-day administrative and HR activities in India and represent the company in good faith and truthfully.

·      Act as the “Competent Person” as per Indian Pharmaceutical regulations with the authority and the responsibility for ensuring an adequate quality system is implemented and maintained:

o  Ensure that a sufficient number of personnel is available and appropriately trained in relation to their tasks.

o  Promote and support the implementation of the quality system. Encourage the staff to do the same.

o  Responsible to assure that the key personnel receive individual training on a regular basis.