The candidate will be responsible for multifaceted tech skills of pharmaceutical product formulation development & technology transfers, right from stages of formulation development to scale up & commercial scale process validation at various contract manufacturing sites across Asian region. Going forward, life cycle management regards to manufacturing technology, new raw material qualification & trouble shooting shall be handled.
The role includes tech transfer of new/existing products to contract manufacturing (CM) locations and to collaborate/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 on various technical tasks during product life cycle management. Monitor, review, approve technical documents & the stability study 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 Jakarta Indonesia & will report to Sr. Manager MPD -Process (B2) BB AMA PHC based out at Mumbai. There are 3 sub-functional wings of MPD viz. Process Development &, Pkg. Material development.
MPD AMA PHC BB team had total 12 No. of FTEs stationed at India Mumbai.
How success looks like
Tech transfer of existing products manufactured at Existing contract manufacturing (CM) locations in Indonesia to New contract manufacturing locations & those are exported to different markets within Asean Countries. Role needs travelling to CM locations across region (66-75% travel time needed for this role)
Participation in NSS & Technical trouble shooting activities at manufacturing locations (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 requirement. Review & approvals of technical documents & data of Dossier for different markets as per Part P & Part S technical part of CTD /Non CTD dossier.
Participate in review of stability study of various batches incubated in line with Asian, ICH/WHO stability guidelines & related task thereof.
Participate in supplier qualification of in scope raw materials being used in the formulation & to follow respective SOP for material qualification. To liaison with Safety Team regards to safety clearance of individual raw materials.
Responsibilities of the role
Coordination with MPD (process, Analytical, Pkg Function) and various Multi-functional Teams (ESS QA, GTM QA, CM site production & QA, CQA, ESS Operations, Purchases) 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 technical documents like TTP/MFR/HTS/TTR prior & post TT and dossiers of prospective C&G products to be outsourced.
Shall lead the supplier qualification activities per P&G SOP for qualification of New Supplier.
Participate in periodic meetings with multi-functional Teams and opine/present on technical matters so to update leadership & MFT members on the progress of regional projects’ from MPD Process PoV.
Ownership of document management software (VEEVA) for initiating change control, deviation & CAPA systems including create/review/approve technical standards for RM, Intermediates and FG.
Ensure compliance to P&G PHC SOPs those impacts MPD Process function. Participate in internal quality audits , its compliance & draft the response to audit observations.
Creation/review of technical writeup that is to be furnished to BOH in response to Deficiency letter issued.
Participation in stated below activities, Documentation, review of stability studies i.e. Initiation & maintenance of stability data of following types of batches.
To support MPD – Compliance Function in ensuring internal & external regulations in this regards.
Shall be responsible for review & interpretation of stability results [have sound knowledge of ICH & WHO guidelines on OOS/OOT, Stability studies]
Existing site to New Site Tech. Transferred products Evaluation batches, Non- commercial PV batches & commercial PV batches.
Savings initiatives (NSS) & Business Continuity Plan Initiatives– batches e.g. commercial PV batches/Small scale (EO) batches.
Role Requirements
Sound knowledge (10-14 years) of various dosage forms having expertise in handling /trouble shooting in various equipment used in commercial scale manufacturing of these dosage forms e.g. FBP granulation (Top spray, bottom spray) & Film coating, Sugar-coating tablet techniques, along with hard Gelatine capsules, Oral Liquid, Nasal & Injection [SVP]dosage form is a needed skill.
Excellent communication, interpersonal skills, power point presentation skills, both oral and written English & Bahasa (Indonesia).
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 [ pre & post Technology Transfer documentation] is required & which shall be aligned with Global Technical/quality guidelines viz, Asian, ICH, WHO. Expert in compose/review of CTD dossier quality module – Part P& Part S.
Job Qualifications
Master degree in Pharmaceutical sciences /Ph. D. in pharmaceutical science from a reputed College
Master’s degree in business administration from recognized institute, would be an add-on qualification for the role.
10-14 years of experience
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 Segmentation
- Experienced Professionals
