Senior General Manager - Production

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Piramal Pharma Solutions Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Senior General Manager - Production Job Description

ESSENTIAL QUALIFICATION

Bachelor’s degree in applicable field (Chemical); Master’s degree from Chemical is also preferred

KEY STAKEHOLDERS: EXTERNAL

Statutory and Regulatory agencies, External Suppliers & Customers (on need basis)

KEY STAKEHOLDERS: INTERNAL

Cross-functional teams at Digwal site, Business/ Site Heads and other functions like Production, QA, QC, HR, TSD, SCM, E&M & Projects, etc. at sites.

RELEVANT EXPERIENCE

• Vibrant experience professional 18-22 years of experience in any Pharma companies with experience of Production in API/Chemical .
• Well-organized and detailed oriented professional, with strong verbal and written communication skills

JOB OVERVIEW

Ensure PPS Digwal site is manufacturing the products in line with our core values & ethical practices

Ensure products manufactured at PPS Digwal site are in compliance with applicable regulatory and internal requirements .

Ensure systems at PPS Digwal site are in synchronization with current regulations & customer expectations KEY RESPONSIBILITIES KEY RESPONSIBILITIES

•Coordinates with and reports to Unit Head the development of overall Quality and yield of intermediates and product.

•Develops and administers policies covering his areas of operations needed to strengthen capabilities of manufacturing operation to attain Quality &Yield. Receives guidance and instructions from Unit Head.

•Analyses complaint data from the customer.

•Review the consumption coefficient statement for all raw materials and intermediates & send copies to V.P. Office.

•Makes regular personal inspection of all activities under his control.

•Ensures process problem / deviations are solved and rectified within a set of time frame, co-ordination / follow up with all the departments like QC, QA, E&M & Store.

•Keeps all process related matters highly confidential

•Ensuring strict compliance & CGMP norms.

•Looks after Unit -1 & Unit - 2 Production.

•Identification of Risks & Hazards, Environmental aspects & evaluation and review the same.

•Ensure compliance of legal and other requirements related to ISO14001:2004 and OHSAS 18001:1999.

•Develop objectives, targets and programmes under EMS & OHSMS.

•Institute operational controls, monitors the key characteristics, carry out root cause analysis for the Non- conformity and take CAPA.

•Ensure continual improvement in OHS & EMS Management Systems.

•Identify SHE training needs for awareness and Competence.

•Ensure SHE requirements with reference to contracted services and service providers.

•And also responsible for the work of senior in absence of senior.

•Ensure optimum utilization of manpower and resources.

•Prepare the gaps in training of personnel and ensure proper training is imparted to bridge the gaps.

•Leading the manufacturing team in investigation and proper CAPA.

•Ensure the sustainability of CAPAs proposed.

•Ensure audit readiness at all times.

•Escalation any gaps between procedures and practices to ensure they are addressed properly.

•Responsible for the job responsibilities of his immediate senior in his absence.

• Responsible to follow ALCOA+ Principles & Practices on their routine work and create awareness to shop floor team to reduce the ALCOA+ errors

KEY COMPETENCIES

• Strong Analytical Skills & knowledge of MS Office
• Ability to manage a large team and guide them to achieve functional objectives
• Stakeholder management – internal and external
• Ability to anticipate the issues in advance and put mitigation plan in place to avoid business impact