MANAGER - MPD PROCESS

Job description

P&G was founded over 180 years ago as a simple soap and candle company. Today, we're the world’s largest consumer goods company and home to iconic, trusted brands that make life a little bit easier in small but significant ways. We've spanned three centuries thanks to three simple ideas: leadership, innovation and citizenship. The insight, innovation and passion of hardworking teams has helped us grow into a global company that is governed responsibly and ethically, that is open and clear, and that supports good causes and protects the environment. This is a place where you can be proud to work and do something that matters.

Dedication from Us:

You'll be at the core of breakthrough innovations, be given exciting assignments, lead initiatives, and take ownership and responsibility, in creative workspaces where new insights thrive. All the while, you'll receive outstanding training to help you become a leader in your field.

What we Offer:

Continuous mentorship – you will collaborate with peers and receive both formal training as well as day-to-day mentoring from your manager multifaceted and encouraging work environment– employees are at the centre, we value every individual and support initiatives, promoting agility and work/life balance.

Overview of the job:

A new BAND 1 position at Material Process Delivery (MPD) Base Business (BB) department (sub function of Product Supply) for market Asia, Middle, East Africa (AMA) region. Position is based out of Mumbai & however is a location free role & so need travel to different location across region for TT activity need based.

The candidate will be responsible for multifaceted tech skills of pharmaceutical product development & technology transfers, right from stages of formulation development to scale up & process validation at various contract manufacturing sites across India + other AMA region.

The role includes tech transfer of new/existing products to contract manufacturing (CM) locations and support to multi-function teams (ESS, Production, QA, Procurement, CM site MFTs) during manufacturing of initial EO batches, validation batches.

The role requires co-ordination with MPD- Process team members & MFTs for various technical tasks & during product life cycle management.

Monitor, review, approve stability data of commercial/Non-commercial PV batches kept at various conditions in line with Asian, ICH/WHO stability guidelines.

Your team

The New BAND 1 role shall be based out at GO Mumbai & will report to Sr. Manager MPD -Process (B2) BB AMA PHC based out at GO Mumbai.

There are 3 sub-functional wings of MPD viz. Process Development & Analytical development, Pkg. development.

MPD AMA PHC BB team had total 17 No. Of FTEs stationed at various locations across PAN India viz GO Mumbai, PPI Lab Goa, Ahmedabad & Hyderabad.

How success looks like

·  Tech transfer of new/existing products to contract manufacturing (CM) locations across AMA region, as well site transfer of Product/s from AMA region to India (regional TT) to different markets. Extensive travelling to CM locations across AMA (66-75% travel time needed for this role)
·  Participation in NSS & Technical trouble shooting activities (need based).
·  Compliance to various P&G system like Digital specs. Management & Quality system, e.g. Veeva for CCP, Deviation management, CAPA.
·  Liaison with LRA /LCM folks for various RA requirements as per BOH. Review & approvals of Technical data of Dossier for different markets as per Part P& Part S requirements of CTD dossier.
·  Demonstration of stability study of various batches incubated in line with Asian, ICH/WHO stability guidelines at PPI Analytical Goa lab & related task thereof.
·  MPD process lab at Goa upkeep- Departmental SOPs Management, CQA Audits & its compliances.

Responsibilities of the role

• Coordination with MPD (process, ADL, Pkg) and various Multi-functional Teams (ESS QA, site QA, CQA, Purchases, ESS Operations) so to facilitate support in Technology Transfer (TT) of products at existing & new CM [contract manufacturing] locations across AMA region as well as to co-ordinate with other region while product TT is planned from sending units of other region e.g. EU, LATAM.

• Review & approve various tech. documents like TTP/MFR/HTS/TTR prior & post TT and dossiers of prospective C&G products to be outsourced.

• Participate in periodic meetings with multi-functional teams and opine/present on technical matters so to update group of MFTS on the progress of India & regional projects’ from MPD Process PoV.

• Maintain Process lab equipment at PPI Lab, Goa (Calibration and preventive maintenance) and to liaison day to day with PPI Lab Goa on progress of tasks thereof.

• Ownership of document management software (VEEVA) for change control, deviation & CAPA systems including create/review/approve technical standards for RM, Intermediates and FG.

• Maintenance of MPD Process labs SOPs & Participate in internal quality audits & its compliance.

• Generation of Capex & Revenue budgets for MPD – Process function having different cost centres.

• Participation in given below activities, Documentation, review of stability studies i.e. Initiation & maintenance of stability data of following types of batches

A) Existing site to New Site Tech. Transferred products Evaluation batches, Non- commercial PV batches & commercial PV batches.
B) Savings (NSS) & Business Continuity Plan Initiatives– batches e.g. commercial PV batches/Small scale (EO) batches.

Role Requirements

·  Sound knowledge (10-12 years) of tablet dosage with subject matter expertise in FBP granulation (Top spray, bottom spray) & Sugar-coated tablet techniques, Hard Gelatine capsules dosage form, Injection

         dosage form is a needed skill for the role.

·  Excellent communication, interpersonal skills, power point presentation skills, both oral and written English. The understanding of regional language - Bahasa (Indonesia) will be an added advantage.
·  Agile, shall have good managerial skills, shall be a team leader and should have problem solving ability.
·  Should have a positive attitude, result oriented, competent and a good team-player with a customer Centric approach.
·  Good digital/soft skills to work in the digitized space required for technical documents' generation.
·  Good Project Management, Planning & Organizing skills.
·  knowledge of various ICH guidelines on stability, process validation and quality & risk Management, Pharmacopoeia like IP/BP/USP, EP etc.
·  Sound knowledge of technical documentation[ role pre & post Technology Transfer] is required which shall be aligned with Global quality guidelines viz, Asian, ICH, WHO. Expert in compose/review of CTD dossier quality module – Part P& Part S.

Job Qualifications

Master of Pharmacy in Pharmaceutics /Ph. D. in pharmaceutical science from a reputed College

+ MBA would be an add-on qualification for the role.

About us

We produce globally recognized brands and we grow the best business leaders in the industry. With a portfolio of trusted brands as diverse as ours, it is paramount our leaders are able to lead with courage the vast array of brands, categories and functions. We serve consumers around the world with one of the strongest portfolios of trusted, quality, leadership brands, including Always®, Ariel®, Gillette®, Head & Shoulders®, Herbal Essences®, Oral-B®, Pampers®, Pantene®, Tampax® and more. Our community includes operations in approximately 70 countries worldwide.

Visit  http://www.pg.com  to know more.

We are an equal opportunity employer and value diversity at our company. We do not discriminate against individuals on the basis of race, color, gender, age, national origin, religion, sexual orientation, gender identity or expression, marital status, citizenship, disability, HIV/AIDS status, or any other legally protected factor.

Job Schedule
Full time

Job Number
R000096541

Job Segmentation
Experienced Professionals (Job Segmentation)